NZ535902A

NZ535902A - Orthotic with deep heeled cup, medial heel wedge and arch support, and lower profiled lateral mid-foot and flat forefoot regions

Info

Publication number: NZ535902A
Application number: NZ53590204A
Authority: NZ
Inventors: Gregory Read Woolman
Original assignee: Foot Bionics Ltd
Priority date: 2004-10-13
Filing date: 2004-10-13
Publication date: 2006-08-31

Abstract

The orthotic has a deep heeled cup, medial heel wedge and arch support, and lower profiled lateral mid-foot and flat forefoot regions.

Description

<div class="application article clearfix" id="description"> 5359 Patents Form No. 5 Patents Act 1953 After Provisional No. 535902 Dated 13 October 2004 Complete Specification AN ORTHOTIC We, FOOTBIONICS LIMITED of 275 Papanui Road, Christchurch, New Zealand, a New Zealand company hereby declare the invention for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement: NOW AMENDED An Orthotic Field of the Invention The invention relates to an orthotic and particialar/v to a corrective orthotic device for the foot that is worn inside a user's fpotyOear. Background to the Invention The human foot is a complex append^ge^that performs many roles during ambulation. Each foot consists of 7$ pones, approximately 33 joints, 19 muscles, and over 100 ligaments. Ir/a jffetime, feet carry the average person approximately 70,000 miles. Not only must the foot absorb around reaction forces, but it must also act as a stable platform for the bodies/lower limbs, adapt itself to uneven surfaces, as well as to provide an effiofen\i propulsion for the lower limb. The foot is considered as an interface? between a ground supporting surface and the leg. Thus foot movements can /dictate both movements and movement patterns that occur further up tne /ower limb - i.e. at the knee, and hip joints. The behaviour of the foot/cai/also influence the impact forces that occur within the leg. Should the foot assume an abnormal position during weight bearing then injuries or conditiansAiay occur to both the foot and/or the lower limbs. There has been much research to support the use of orthotic devices in the treatment of/root and lower limb conditions (Blake and Denton 1985, Donatelli 1988, Sim/in/l989, Gross et al 1991, Ferguson et al 1991, Orteza 1992, Thompson at al 1992, Moraros and Hodge 1993, Johanson 1994, Eng and Pierryn/w^Ki 1994, Kogler 1996, Saxena and Haddad 1998) to site but a few reference Orthotic devices are worn inside a user's footwear to attempt to normalise jading through the sole of the foot, and/or control the movements of the foot 2 NOW AMENDED and/or segments of the foot so that these movement^ occur both within a normal time sequence as well as within a normal range/of joint motion. Medical practitioners including doctors, physical therapists, podiatrists, and orthotists commonly use and prescribe orthotio^ devices for such injuries and/or conditions. These orthoses range from individually prescribed and manufactured devices, to pre-fabricated ovefr the counter devices. The benefits of the latter type are for the practitioner to be able to immediately dispense the device to ascertain cause smd/effect relationship without the additional cost and time delay in usinc/ a/prescription type device. The benefits of using a pre-fabricated devicp also include the ease of dispensing, ease of modification or adjustment, ai/d (greatly improved patient tolerance to the device compared to the prescription^ype. All foot types are both structurally yand functionally different, and it must be understood that a pre-fabricated product cannot be expected to accurately fit and function to the user's exyct/Diomechanical requirements. Pre-fabricated devices can however be specifically adjusted or modified immediately so that they function in a way that/oetier relates to the individual users foot type. The use of pre-moulded/innersoles for athletic footwear is now common practice for most of tne major athletic shoe companies. Whilst most of these innersoles are constructed from closed cell foam none known to the applicant are profiled or designed in such a way as to offer significant medial support. The known inne/soles are generally thin and flimsy in design. Most of thes prior art orthotic devices have been presented as being structurally corrective or supportive for those users suffering from either foot pain and/or/abnormal foot function. These orthotic devices are generally either % length, or are constructed from a rigid plastic material comprising the orthotic smell. These orthoses all offer less support in the medial heel and arcl/reaion and are low in profile. 3 NOW AMENDED One form of pre-moulded full-length innersole is offered a polyethylene blank form and this is described in NZ Patent specificationNo. 196010. This innersole is made through a milling process. NZ Patent specification No. 196010 describes a construction with a flat profile Inowever the innersole needs to be customised to the individuals foot/shape given that it is not recommended to be dispensed in it's existing Jola/ik flat form. U.S. Patent specification No. 5184409 describes a laminatecyform however it has a low arch and medial heel profile and offers little medial support. U.S. Patent specification No. 4,823,420 discloses a ful/ler/gth contour moulded insole, in several layers. This offers a shallow heel >cup, little arch profile, and little medial support. A mouldable full-lengtn crevice is described in U.S. Patent specification No. 3,895,405. This is a/thirf completely flat thermoplastic sheet moulded by heat around the user's woy Similarly a thin flat insole that can be moulded to the user's foot is d^scjnbed in U.S. Patent specification No. 2,760,281. Another custom moGldible full-length shock absorbing insole is disclosed in U.S. Patent specification No. 4,674,204. This highlights an extremely deep heel and mid^oot/cup where no arch is identified. A large variety of other orthotic devices are currently available and examples are those described in the l/S and other patent specifications identified below. These are to numerous'to/comment on individually. 6604301 2003/ j I August Manoli 6618960 200/ / March Brown 6460275 B1 CM October Bennett 6038793 2u 00 March Kendall D485667S > /2004 January Kielt 5036851 / /991 August Cohen 4232457/ / '1980 November Mosher 4250886 / 1981 February Riso 4439934/ 1984 April Brown 451/981 1985 May Santopietro 4610/01 1986 September Brown /59/196 1986 July Brown 4 NOW AMENDED 4791736 1988 December Phillips D489521 S 2004 May Bacon D474590 S 2003 May Bacon D483556 S 2003 December Zehr Des. 353936 1995 January Vasyli / 4702255 1987 October Schenky 4686993 1987 August Grumb/ine Des. 263644 1982 April Vinn£co(jr 4530173 1985 July JesfinsKy Des. 300686 1989 April c o ik 2401514 1946 June /Scholl Des. 358249 1995 May / Vasyli Des. 357349 1995 April / A/asyli Des. 353936 1995 January / Vasyli 6681501 B1 2004 Janua/y / Polifroni D4625105 2002 September Goodrich CA2439347 2004 Mafc W Frederick 2653396 1953 September Gottlieb An object of the present/inyention is to overcome the disadvantages inherent in known orthotics and/o provide user's with a useful alternative choice. Further objects aria advantages of the invention will become apparent from the following description which is given by way of example only. Summary of tne/nvention According Jto f broadest aspect of the invention there is provided an orthotic compression/ moulded from a closed cell foam material, the orthotic including a deefy heel cup incorporating an intrinsic varus or medial heel wedge, a highe/ aind thicker profiled medial arch support region, a lower profiled and thin/er/ateral midfoot region, and a flat forefoot region. 5 NOW AMENDED The orthotic device provides stability and medial afupport to the foot particularly where the foot has a tendency to pronate excessively. The orthotic device is preferably constructed from sr nc/n-rigid or semi-flexible material or materials that can vary in density frpm^oft foam for additional cushioning, to firm foam for additional support. The orthotic device provides support which is i/iaximised in the medial heel and medial arch whilst also forming around/ih^lateral heel and lateral midfoot region. This orthotic device can be supplied a/blank which is further heat moulded and customised to the shape of jL yser's foot by a podiatrist or health professional. The orthotic device is also desic/ned in a scaled size range. The orthotic is preferably provided with a fabric covering layer. The invention presented & an "orthotic" device and is pre-moulded in construction and the/present invention relates to both the process of manufacture and the -materials used in its construction. Further aspects pi tne invention will become apparent from the following descriptions whiph ^re given by way of example only. Description/of fne Drawings Examples^ of the invention will now be described with reference to the accompanying drawings in which: figure 1 is a perspective view from above of an example of right foot 'ortnotic according to the invention; iponz ®5 Mm 1 NOW AMENDED Figure 2 is a perspective view from below of the ortpotjic shown in Figure 1; Figure 3 is a perspective view from above orthotic according to the invention; example of left foot Figure 4 is a perspective view from below/of fhe orthotic shown in Figure 3; Figure 5 is an inside view of the orthotic sfiown in Figures 3 and 4; Figure 6 is an underside view of the orthotic shown in Figures 3, 4 and 5; Figure 7 is a view from the outsnde'of the orthotic shown in Figures 3 to 6; Figure 8 is a section throudn tne left foot orthotic shown in Figures 3 to 7 on the lines A-A shown in Figiare 6; and Figure 9 shows a senes/of cross sections through the left foot orthotic shown in Figures 3 1:p 8/on the section lines B-B, C-C, D-D, E-E, F-F and G-G the position ofywhich are identified in Figure 6. Description of the/Examples An example of tne /nvention will now be described with reference to a left foot orthotic as she>wnr in Figures 3 to 9. It is to be appreciated that the right foot orthotic shown p Figures 1 and 2 is of similar construction and its shape is a mirror image off that shown and described with reference to Figures 3 to 9. The orthotic which is compression moulded from a closed cell foam material has &d&ep heel cup region indicated by arrow 1. This includes an intrinsic vari/s or medial heel wedge region 2, a higher and thicker profiled medial arch support region 3, a lower profiled and thinner lateral midfoot region 4, and a /fat/orefoot region 5. 7 NOW AMENDED The orthotic device is supplied as a compression mouraep blank in a prefabricated and shaped form which provides the foot support particularly within the regions of the medial heel and medial arch region^. / In providing additional support to these areas the material thickness is greater in the medial heel compared to the lateral heel^o^s to act like a corrective wedge for foot types where inward rolling offh& heel occurs. This can be seen in Figures 1 and 3. / / In use the orthotic device which is inserted ii{a user's footwear provides both control of excessive joint motion of ph& foot and lower limb, improved structural malalignment of the foot hr\a lower limb, improves the timing sequence of foot and lower limb motfoiV as well as it can improve cushioning of the users foot. The orthotic is prescribed for the user to improve the structural position of the foot apd /ower limb, and or relieve user pain or discomfort. / / The orthotic preferably con/prises a one solid piece full-length "closed cell foam" shell tapered and pre-fprmed. The individual regions of the orthotic can comprise a top surface tpatAas direct contact with the user's foot, medial and lateral sides, a flat /focefoot extension, and an under-surface closely resembling a "positivef snape of the top surface. The top surface ii/cluaes a downwardly concave heel cup, an upwardly flared lateral edge, ary upwardly flared medial edge that is higher and thicker than the lateral edge stich as to include an arch support, and finally a flat forefoot region that ^Wnds anteriorly. The thickness of the orthotic at the heel is slightly thicker than that of the forefoot so that the orthotic is tapered anteriorly m the top surface of the heel cup it is preferably concaved in the following -approximate proportions, 40° medially, 35° laterally and 30° poste/orjy and that the heel cup is thicker medially than it is laterally. Tms lop surface can or can not be covered with a fabric material that is lammated or bonded to the foam. 8 NOW AMENDED The orthotics under surface (plantar) is also contoured so that it forms an upwardly rounded profile and is not completely flat \jkeAhe inner of a shoe. The rounded profile ensures that a large amount ofythisf under surface makes no contact with the sole of the user's shoe. Thi/ under surface closely resembles a "positive form" of the top surface. / / The orthotics under surface mid section is concave longitudinally so that this area does not contact the shoe howevei/it m\\\ flex downward on weight bearing to allow some tolerable mid-foot n/otipn to occur. The under surface can or can not include specific areas of additional and separate cushioning material such asr cushion gel or foam directly beneath the weight bearing portion of the heel (calcaneus) and or directly beneath the forefoot in the region of the metatarsal heads and or hallux. The under surface heel cup contour closely follows the top surface heel cup angulations as described abpv&. The orthotic arch profile/is /approximately 45° transversely through the mid-arch region such that iy upwardly contours to the arch of the user's foot. This reaches both a pealy height of approximately 36mm, and peak thickness of approximately 12.5mmAor the small size orthotic. In addition the anterior arch angle from the hignept point is declined 30° from the highest point of the arch longitudinally \.o/\he point at whic(i the arch tapers down to become the forefoot. / / The orthotic device can be constructed of a mixture of closed cell foam containing ethylene vinyl acetate, polyethylene, or both. Alternatively the device csaiybe constructed of R20; closed cell foam R21; being ethylene vinyl acetate arnd/or polyethylene or other cushioning based foam materials or a combination thereof. 9 NOW AMENDED The orthotic device is preferably constructed from a maternal density between a shore of 25 and a shore of 80. / / The method of manufacture for the orthotic is by compression of the foam or foams between 2 rigid moulds. This can be performed using either "cold foam" and "heated moulds" or "heated foam" and/'c^ld moulds". The orthotic device can have a softer foam/material directly laminated to its upper surface so that more comfort and cusnicyiing is provided for the user. The orthotic device can also have a denser layer of foam material laminated beneath the under surface from the regipn of the heel to a region anteriorly that is immediately posterior to the metatarsal heads. The orthotic device can be presented in a pre-moulded corrective form. This form will change slightly as the/user's foot compresses the material over time. It can however be further dustom formed to the user's foot through the application of heat to the onhaWc material. The application of heat can take several forms however \j i^envisaged that heating the material using a heating element, an oveX, heated air or other heating methods for a period of time such that the foam semens sufficiently that it can form easily to the shape of the users foot durij/g i/ormal weight bearing. The orthotic device As preferably presented in a selection of proportionally scaled sizes. Thiar range to be available in approximately 10 ranging from children's to lafrgef adult sizes. These can be trimmed to the exact shoe size when being fitted. Where \a tj/e foregoing description particular features are described it is envisaged/that their equivalents may be substituted as if they were set forth herein. / 10 NOW AMENDED Claims / / 1. An orthotic compression moulded from a closed/cell foam material, the orthotic including a deep heel cup incorporatrng/an intrinsic varus or medial heel wedge, a higher and thicker priofilefa medial arch support region, a lower profiled and thinner lateral nmdfoot region, and a flat forefoot region. / / An orthotic as claimed in claim 1 wWch/provides stability and medial support to the foot particularly wbfere the foot has a tendency to pronate excessively. / / 3. An orthotic as claimed in claim A and claim 2 wherein the orthotic device is constructed from & /on-rigid or semi-flexible material or materials that can vary in elensity from soft foam for additional cushioning, to firm foam for additional support. 4. An orthotic as claimed in/;laim 3 wherein the orthotic device provides support which is maximised in the medial heel and medial arch whilst also forming arounoi a/ateral heel and lateral midfoot region. An orthotic as maimed in any one of the preceding claims wherein the orthotic is pro/idea with a fabric covering layer. 6. An orthotic/as claimed in any one of the preceding claims wherein the orthotic device is pre-moulded in construction and provides additional support by increasing the material thickness in the medial heel compared to the lateral heel so as to act like a corrective wedge for foot/types where inward rolling of the heel occurs. 7. An Orthotic as claimed in any one of the preceding claims in which the / orthotic device comprises a one solid piece full-length "closed cell / /oam" shell tapered and pre-formed. 12 'IPONZ ®5 NOW AMENDED 8. An orthotic as claimed in claim 7 wherein the one ^olijd piece full-length closed cell foam shell comprises a top surface fha^has direct contact with the user's foot, medial and lateral sides, f flaft forefoot extension, and an under-surface closely resembling a "positive" shape of the top surface. 9. An orthotic as claimed in claim 8 wherein/the top surface includes a downwardly concave heel cup, an ujbwjardly flared lateral edge, an upwardly flared medial edge that is JnigKer and thicker than the lateral edge such as to include an arch/si^>port, and finally a flat forefoot region that extends anteriorly. 10. An orthotic as claimed in claip at the heel is slightly thickery is tapered anteriorly. 'wherein the thickness of the orthotic that of the forefoot so that the orthotic 11. An orthotic as claimed/n (claim 10 wherein the top surface of the heel cup is concaved in the following approximate proportions, 40° medially, 35° laterally and 30/p9Steriorly and that the heel cup is thicker medially than it is laterally., 12.An orthotic a^claimed in claim 11 wherein the top surface can be covered with^ ffabric material that is laminated or bonded to the foam. 13. An orthotic gfe claimed in any one of claims 8 to 12 where the orthotic deviceV itrider surface (plantar) is contoured so that it forms an upwapflly/rounded profile and is not completely flat like the inner of a shoe 14.^n orthotic as claimed in claim 13 wherein the rounded profile ensures at a large amount of this under surface makes no contact with the fole of the user's shoe. 13 IPONZ "5 NOW AMENDED 15. An orthotic as claimed in claim 14 wherein the under surface closely resembles a "positive form" of the top surface. / / 16. An orthotic as claimed in any one of claims n 3 to 15 wherein the orthotic device's under surface mid section/s orancave longitudinally so that this area does not contact the sho^but it will flex downward on weight bearing to allow some tolerable raid-foot motion to occur. 17.An orthotic as claimed in claim 1w wnerein the under surface can include specific areas of additional and separate cushioning material such as cushion gel or foam directly/beneath the heel (calcaneus) and or directly beneath the forefoot./ / 18. An orthotic as claimed in clanm/l6 wherein the under surface heel cup contour closely follows the/TO|/surface heel cup angulations. 19. An orthotic as claimed/n ^iny one of the preceding claims wherein the orthotic arch profile iar approximately 45° transversely through the mid-arch region such that iyupwardly contours to the arch of the user's foot. 20. An orthotic as ^claimed in claim 19 wherein the orthotic arch profile reaches a peaK height of approximately 36mm, and peak thickness of approximately 12.5mm for a small size orthotic. 21. An orthotic as claimed in claim 19 or claim 20 wherein the anterior arch angle Worry the highest point is declined 30° from the highest point of the arch/longitudinally to the point at which the arch tapers down to become the forefoot. 22. An (orthotic as claimed in any one of the preceding claims wherein the /orthotic device is constructed of a mixture of closed cell foam / (containing ethylene vinyl acetate, polyethylene, or both. 14 rIPONZ 05 hn, US NOW AMENDED 23. An orthotic as claimed in any one of the preceding daims wherein the orthotic device is constructed from a material d^nsj/y between a shore of 25 and a shore of 80. 24. An orthotic as claimed in claim 23 wherei^ tbfe orthotic device has a softer foam material directly laminated to its ypper surface so that more comfort and cushioning is provided for tl/e 25. An orthotic as claimed in claim 24 wherein the orthotic device has a denser layer of foam material laminated beneath the under surface from the region of the heel to 3/ region anteriorly that is immediately posterior to the metatarsal heac 26. An orthotic as claimed An /any one of the preceding claims manufactured by compres^io/ moulding of the foam or foams between 2 rigid moulds. 27. An orthotic as claimed /n claim 1 and substantially as hereinbefore described with reference to the accompanying drawings. 28. An orthotic manufacturing method in which an orthotic device as claimed in clap ris manufactured in a compression moulding process from either /coljd foam", "heated moulds" or "heated foam" and "cold moulds. 29. An orthoti^manufacturing method as claimed in claim 28 wherein the orthotic device is further custom formed to the user's foot through the application of heat to the orthotic material for a period of time such that thes orthotic material softens sufficiently so that it moulds to the shape iff tj/e user's foot and as the orthotic material cools it sets to it's newly led shape. f3(/.An orthotic manufacturing method as claimed in claim 29 wherein the application of heat to the orthotic material can take several forms such IPONZ 15 n 0 5 I'lr.. „ j'6 NOW AMENDED as heating the material using a heating element, af\ o/en, heated air or other heating methods 31. An orthotic manufacturing method as clairfiecT in claim 28 and substantially as hereinbefore described /wtyn reference to the accompanying drawings. IPONZ 05 Mai 2006 rIPOl\iz - " *006 16 AS AMENDED Received at IPONZ 13 January 2011 An Orthotic Field of the Invention The invention relates to an orthotic and particularly to a corrective orthotic device for the foot that is worn inside a user's footwear. Background to the Invention The human foot is a complex appendage that performs many roles during ambulation. Each foot consists of 26 bones, approximately 33 joints, 19 muscles, and over 100 ligaments. In a lifetime, feet carry the average person approximately 70,000 miles. Not only must the foot absorb ground reaction forces, but it must also act as a stable platform for the bodies lower limbs, adapt itself to uneven surfaces, as well as to provide an efficient propulsion for the lower limb. The foot is considered as an interface between a ground supporting surface and the leg. Thus foot movements can dictate both movements and movement patterns that occur further up the lower limb - i.e. at the knee, and hip joints. The behaviour of the foot can also influence the impact forces that occur within the leg. Should the foot assume an abnormal position during weight bearing then injuries or conditions may occur to both the foot and/or the lower limbs. There has been much research to support the use of orthotic devices in the treatment of foot and lower limb conditions (Blake and Denton 1985, Donatelli 1988, Simkin 1989, Gross et al 1991, Ferguson et al 1991, Orteza 1992, Thompson et al 1992, Moraros and Hodge 1993, Johanson 1994, Eng and Pierrynowski 1994, Kogler 1996, Saxena and Haddad 1998) to site but a few references. Orthotic devices are worn inside a user's footwear to attempt to normalise loading through the sole of the foot, and/or control the movements of the foot 2 AS AMEN DED Received at IPONZ 13 January 2011 and/or segments of the foot so that these movements occur both within a normal time sequence as well as within a normal range of joint motion. Medical practitioners including doctors, physical therapists, podiatrists, and orthotists commonly use and prescribe orthotic devices for such injuries and/or conditions. These orthoses range from individually prescribed and manufactured devices, to pre-fabricated over the counter devices. The benefits of the latter type are for the practitioner to be able to immediately dispense the device to ascertain cause and effect relationship without the additional cost and time delay in using a prescription type device. The benefits of using a pre-fabricated device also include the ease of dispensing, ease of modification or adjustment, and greatly improved patient tolerance to the device compared to the prescription type. All foot types are both structurally and functionally different, and it must be understood that a pre-fabricated product cannot be expected to accurately fit and function to the user's exact biomechanical requirements. Pre-fabricated devices can however be specifically adjusted or modified immediately so that they function in a way that better relates to the individual users foot type. The use of pre-moulded innersoles for athletic footwear is now common practice for most of the major athletic shoe companies. Whilst most of these innersoles are constructed from closed cell foam none known to the applicant are profiled or designed in such a way as to offer significant medial support. The known innersoles are generally thin and flimsy in design. Most of the prior art orthotic devices have been presented as being structurally corrective or supportive for those users suffering from either foot pain and/or abnormal foot function. These orthotic devices are generally either % length, or are constructed from a rigid plastic material comprising the orthotic shell. These orthoses all offer less support in the medial heel and arch region and are low in profile. 3 AS AMENDED Received at IPONZ 13 January 2011 One form of pre-moulded full-length innersole is offered in a polyethylene blank form and this is described in NZ Patent specification No. 196010. This innersole is made through a milling process. NZ Patent specification No. 196010 describes a construction with a flat profile however the innersole needs to be customised to the individuals foot shape given that it is not recommended to be dispensed in it's existing blank flat form. U.S. Patent specification No. 5184409 describes a laminated form however it has a low arch and medial heel profile and offers little medial support. U.S. Patent specification No. 4,823,420 discloses a full-length contour moulded insole, in several layers. This offers a shallow heel cup, little arch profile, and little medial support. A mouldable full-length device is described in U.S. Patent specification No. 3,895,405. This is a thin completely flat thermoplastic sheet moulded by heat around the user's foot. Similarly a thin flat insole that can be moulded to the user's foot is described in U.S. Patent specification No. 2,760,281. Another custom mouldable full-length shock absorbing insole is disclosed in U.S. Patent specification No. 4,674,204. This highlights an extremely deep heel and midfoot cup where no arch is identified. A large variety of other orthotic devices are currently available and examples are those described in the US and other patent specifications identified below. These are to numerous to comment on individually. 6604301 2003 August Manoli 6618960 2003 March Brown 6460275 B1 2002 October Bennett 6038793 2000 March Kendall D485667 S 2004 January Kielt 5036851 1991 August Cohen 4232457 1980 November Mosher 4250886 1981 February Riso 4439934 1984 April Brown 4517981 1985 May Santopietro 4610101 1986 September Brown 4597196 1986 July Brown 4 AS AMENDED Received at IPONZ 13 January 2011 4791736 1988 December Phillips D489521 S 2004 May Bacon D474590 S 2003 May Bacon D483556 S 2003 December Zehr Des. 353936 1995 January Vasyli 4702255 1987 October Schenkl 4686993 1987 August Grumbine Des. 263644 1982 April Vinnecour 4530173 1985 July Jesinsky Des. 300686 1989 April Peterson 2401514 1946 June Scholl Des. 358249 1995 May Vasyli Des. 357349 1995 April Vasyli Des. 353936 1995 January Vasyli 6681501 B1 2004 January Polifroni D4625105 2002 September Goodrich CA2439347 2004 March Frederick 2653396 1953 September Gottlieb An object of the present invention is to overcome the disadvantages inherent in known orthotics and to provide user's with a useful alternative choice. Further objects and advantages of the invention will become apparent from the following description which is given by way of example only. Summary of the Invention According to a broadest aspect of the invention there is provided a pre-moulded ready to use closed cell foam orthotic which is compression moulded between shaped top and bottom moulds, the orthotic including a deep heel cup incorporating an intrinsic varus or medial heel wedge, a higher and thicker profiled medial arch support region, a lower profiled and thinner lateral midfoot region, a flat forefoot region, a top surface that has direct contact with a user's foot, medial and lateral sides, and wherein an under-surface has a curved and 5 AS AMEN DED Received at IPONZ 13 January 2011 rounded profile throughout the rearfoot and midfoot regions and where transversely this curved surface is almost parallel to the curvature of the top surface, and wherein the undersurface is contoured to form an upwardly rounded profile between the plantarmost rearfoot and forefoot regions so that a large amount of this curved and rounded surface makes no contact with the sole of a user's shoe when there is no load on the top surface. The orthotic device provides stability and medial support to the foot particularly where the foot has a tendency to pronate excessively. The orthotic device is preferably constructed from a non-rigid or semi-flexible material or materials that can vary in density from soft foam for additional cushioning, to firm foam for additional support. The orthotic device provides support which is maximised in the medial heel and medial arch whilst also forming around the lateral heel and lateral midfoot region. This orthotic device can be supplied as a blank which is further heat moulded and customised to the shape of a user's foot by a podiatrist or health professional. The orthotic device is also designed in a scaled size range. The orthotic is preferably provided with a fabric covering layer. The invention presented is an "orthotic" device and is pre-moulded in construction and the present invention relates to both the process of manufacture and the materials used in its construction. Further aspects of the invention will become apparent from the following descriptions which are given by way of example only. Description of the Drawings 6 AS AMEN DED Received at IPONZ 13 January 2011 Examples of the invention will now be described with reference to the accompanying drawings in which: Figure 1 is a perspective view from above of an example of right foot orthotic according to the invention; Figure 2 is a perspective view from below of the orthotic shown in Figure 1; Figure 3 is a perspective view from above of an example of left foot orthotic according to the invention; Figure 4 is a perspective view from below of the orthotic shown in Figure 3; Figure 5 is an inside view of the orthotic shown in Figures 3 and 4; Figure 6 is an underside view of the orthotic shown in Figures 3, 4 and 5; Figure 7 is a view from the outside of the orthotic shown in Figures 3 to 6; Figure 8 is a section through the left foot orthotic shown in Figures 3 to 7 on the lines A-A shown in Figure 6; and Figure 9 shows a series of cross sections through the left foot orthotic shown in Figures 3 to 8 on the section lines B-B, C-C, D-D, E-E, F-F and G-G the position of which are identified in Figure 6. Description of the Examples An example of the invention will now be described with reference to a left foot orthotic as shown in Figures 3 to 9. It is to be appreciated that the right foot 7 AS AMEN DED Received at IPONZ 13 January 2011 orthotic shown in Figures 1 and 2 is of similar construction and its shape is a mirror image of that shown and described with reference to Figures 3 to 9. The orthotic which is compression moulded from a closed cell foam material has a deep heel cup region indicated by arrow 1. This includes an intrinsic varus or medial heel wedge region 2, a higher and thicker profiled medial arch support region 3, a lower profiled and thinner lateral midfoot region 4, and a flat forefoot region 5. The orthotic device is supplied as a compression moulded blank in a prefabricated and shaped form which provides the foot support particularly within the regions of the medial heel and medial arch regions. In providing additional support to these areas the material thickness is greater in the medial heel compared to the lateral heel so as to act like a corrective wedge for foot types where inward rolling of the heel occurs. This can be seen in Figures 1 and 3. In use the orthotic device which is inserted in a user's footwear provides both control of excessive joint motion of the foot and lower limb, improved structural malalignment of the foot and lower limb, improves the timing sequence of foot and lower limb motion, as well as it can improve cushioning of the users foot. The orthotic is prescribed for the user to improve the structural position of the foot and lower limb, and or relieve user pain or discomfort. The orthotic preferably comprises a one solid piece full-length "closed cell foam" shell tapered and pre-formed. The individual regions of the orthotic can comprise a top surface that has direct contact with the user's foot, medial and lateral sides, a flat forefoot extension, and an under-surface closely resembling a "positive" shape of the top surface. The top surface includes a downwardly concave heel cup, an upwardly flared lateral edge, an upwardly flared medial edge that is higher and thicker than the lateral edge such as to include an arch support, and finally a flat forefoot 8 AS AMEN DED Received at IPONZ 13 January 2011 region that extends anteriorly. The thickness of the orthotic at the heel is slightly thicker than that of the forefoot so that the orthotic is tapered anteriorly. At the top surface of the heel cup it is preferably concaved in the following approximate proportions, 40° medially, 35° laterally and 30° posteriorly and that the heel cup is thicker medially than it is laterally. This top surface can be covered with a fabric material that is laminated or bonded to the foam. The orthotics under surface (plantar) is also contoured so that it forms an upwardly rounded profile and is not completely flat like the inner of a shoe. The rounded profile ensures that a large amount of this under surface makes no contact with the sole of the user's shoe. This under surface closely resembles a "positive form" of the top surface. The orthotics under surface mid section is concave longitudinally so that this area does not contact the shoe however it will flex downward on weight bearing to allow some tolerable mid-foot motion to occur. The under surface can include specific areas of additional and separate cushioning material such as cushion gel or foam directly beneath the weight bearing portion of the heel (calcaneus) and or directly beneath the forefoot in the region of the metatarsal heads and or hallux. The under surface heel cup contour closely follows the top surface heel cup angulations as described above. The orthotic arch profile is approximately 45° transversely through the mid-arch region such that it upwardly contours to the arch of the user's foot. This reaches both a peak height of approximately 36mm, and peak thickness of approximately 12.5mm for the small size orthotic. In addition the anterior arch angle from the highest point is declined 30° from the highest point of the arch longitudinally to the point at which the arch tapers down to become the forefoot. 9 AS AMEN DED Received at IPONZ 13 January 2011 The orthotic device can be constructed of a mixture of closed cell foam containing ethylene vinyl acetate, polyethylene, or both. Alternatively the device can be constructed of closed cell foam; being ethylene vinyl acetate and/or polyethylene or other cushioning based foam materials or a combination thereof. The orthotic device is preferably constructed from a material density between a shore of 25 and a shore of 80. The method of manufacture for the orthotic is by compression of the foam or foams between 2 rigid moulds. This can be performed using either "cold foam" and "heated moulds" or "heated foam" and "cold moulds". The orthotic device can have a softer foam material directly laminated to its upper surface so that more comfort and cushioning is provided for the user. The orthotic device can also have a denser layer of foam material laminated beneath the under surface from the region of the heel to a region anteriorly that is immediately posterior to the metatarsal heads. The orthotic device can be presented in a pre-moulded corrective form. This form will change slightly as the user's foot compresses the material over time. It can however be further custom formed to the user's foot through the application of heat to the orthotic material. The application of heat can take several forms however it is envisaged that heating the material using a heating element, an oven, heated air or other heating methods for a period of time such that the foam softens sufficiently that it can form easily to the shape of the users foot during normal weight bearing. The orthotic device is preferably presented in a selection of proportionally scaled sizes. This range to be available in approximately 10 ranging from children's to large adult sizes. These can be trimmed to the exact shoe size when being fitted. 10 AS AMEN DED Received at IPONZ 13 January 2011 Where in the foregoing description particular features are described it is envisaged that their equivalents may be substituted as if they were set forth herein. 11 AS AMEN DED Received at IPONZ 13 January 2011 Examples of the invention have been described and it is envisaged that improvements and modifications can take place without departing from the scope of the attached claims. 12 AS AMEN DED Received at IPONZ 13 January 2011 </div>

Claims

<div class="application article clearfix printTableText" id="claims"> Claims

1. A pre-moulded ready to use closed cell foam orthotic which is compression moulded between shaped top and bottom moulds, the orthotic including a deep heel cup incorporating an intrinsic varus or medial heel wedge, a higher and thicker profiled medial arch support region, a lower profiled and thinner lateral midfoot region, a flat forefoot region, a top surface that has direct contact with a user's foot, medial and lateral sides, and wherein an under-surface has a curved and rounded profile throughout the rearfoot and midfoot regions and where transversely this curved surface is almost parallel to the curvature of the top surface, and wherein the undersurface is contoured to form an upwardly rounded profile between the plantarmost rearfoot and forefoot regions so that a large amount of this curved and rounded surface makes no contact with the sole of a user's shoe when there is no load on the top surface.

2. An orthotic as claimed in claim 1 wherein the under surface heel cup contour closely follows the top surface heel cup angulations.

3. An orthotic as claimed in claim 1 or claim 2 wherein the orthotic device's under surface mid section is concave longitudinally so that this area does not contact the shoe but it will flex downward on weight bearing to allow some tolerable mid-foot motion to occur.

4. An orthotic as claimed in claim 1 wherein the rounded profile ensures that a large amount of the under surface makes no contact with the sole of the user's shoe.

5. An orthotic as claimed in any one of the preceding claims wherein the top surface includes a concave heel cup, an upwardly flared lateral edge, an upwardly flared medial edge that is higher and thicker than the lateral edge such as to include an arch support, and a flat forefoot region that extends anteriorly 13 AS AMEN DED Received at IPONZ 13 January 2011

6. An orthotic as claimed in claim 5 wherein the orthotic device is constructed from a non-rigid or semi-flexible material or materials that can vary in density from soft foam for additional cushioning, to firm foam for additional support.

7. An orthotic as claimed in claim 5 wherein the orthotic device provides support which is maximised in the medial heel and medial arch whilst also forming around a lateral heel and lateral midfoot region.

8. An orthotic as claimed in any one of the preceding claims wherein the orthotic is provided with a fabric covering layer.

9. An orthotic as claimed in any one of the preceding claims wherein the orthotic is compression moulded and provides additional support by increasing the material thickness in the medial heel compared to the lateral heel so as to act like a corrective wedge for foot types where inward rolling of the heel occurs.

10. An orthotic as claimed in any one of the preceding claims in which the orthotic device comprises a one solid piece full-length "closed cell foam" shell tapered and pre-formed.

11. An orthotic as claimed in claim 5 wherein the thickness of the orthotic at the heel is slightly thicker than that of the forefoot so that the orthotic is tapered anteriorly.

12. An orthotic as claimed in claim 11 wherein the top surface of the heel cup is concaved in the following approximate proportions, 40° medially, 35° laterally and 30° posteriorly and that the heel cup is thicker medially than it is laterally. 14 AS AMEN DED Received at IPONZ 13 January 2011

13.An orthotic as claimed in claim 11 wherein the top surface can be covered with a fabric material that is laminated or bonded to the foam.

14. An orthotic as claimed in claim 3 wherein the under surface can include specific areas of additional and separate cushioning material such as cushion gel or foam directly beneath the heel (calcaneus) and or directly beneath the forefoot.

15. An orthotic as claimed in claim 14 wherein the under surface heel cup contour closely follows the top surface heel cup angulations.

16. An orthotic as claimed in any one of the preceding claims wherein the orthotic arch profile is approximately 45° transversely through the mid-arch region such that it upwardly contours to the arch of the user's foot.

17.An orthotic as claimed in claim 16 wherein the orthotic arch profile reaches a peak height of approximately 36mm, and peak thickness of approximately 12.5mm for a small size orthotic.

18. An orthotic as claimed in claim 16 or claim 17 wherein the anterior arch angle from the highest point is declined 30° from the highest point of the arch longitudinally to the point at which the arch tapers down to become the forefoot.

19. An orthotic as claimed in any one of the preceding claims wherein the orthotic device is constructed of a mixture of closed cell foam containing ethylene vinyl acetate, polyethylene, or both.

20. An orthotic as claimed in any one of the preceding claims wherein the orthotic device is constructed from a material density between a shore of 25 and a shore of 80. 15 AS AMEN DED Received at IPONZ 13 January 2011

21. An orthotic as claimed in claim 20 wherein the orthotic device has a softer foam material directly laminated to its upper surface so that more comfort and cushioning is provided for the user.

22. An orthotic as claimed in claim 21 wherein the orthotic device has a denser layer of foam material laminated beneath the under surface from the region of the heel to a region anteriorly that is immediately posterior to the metatarsal heads.

23.An orthotic as claimed in any one of the preceding claims manufactured by compression moulding of the foam or foams between 2 rigid moulds.

24.An orthotic as claimed in claim 1 and substantially as hereinbefore described with reference to the accompanying drawings.

25.An orthotic manufacturing method in which an orthotic device as claimed in claim 1 is manufactured in a compression moulding process from either "cold foam", "heated moulds" or "heated foam" and "cold moulds.

26.An orthotic manufacturing method as claimed in claim 25 wherein the orthotic device is further custom formed to the user's foot through the application of heat to the orthotic material for a period of time such that the orthotic material softens sufficiently so that it moulds to the shape of the user's foot and as the orthotic material cools it sets to it's newly formed shape.

27.An orthotic manufacturing method as claimed in claim 26 wherein the application of heat to the orthotic material can take several forms such as heating the material using a heating element, an oven, heated air or other heating methods 16 AS AMEN DED Received at IPONZ 13 January 2011

28.An orthotic manufacturing method as claimed in claim 25 and substantially as hereinbefore described with reference to the accompanying drawings. 17 </div>