Patent Application
20130110024
This application is a national stage application under 35 USC 371 of International Application No. PCT/JP2010/060820, filed Jun. 25, 2010, which claims priority from Japanese Patent Application No. 2010-006489 filed Jan. 15, 2010, the entire contents of which are incorporated herein by reference.
The present invention relates to a device for correcting hallux valgus used for correction when hallux positioned in an innermost portion of toes is deformed or valgus and a producing method thereof.
Hallux valgus is a deformation in which hallux is valgus in a “ <shape” in the first metatarsophalangeal joint and is an ailment that very frequently occurs particularly among women. If the deformation advances, a gait disorder is caused and daily life is extremely obstructed.
In the treatment of hallux valgus, it is important to correct the deformed hallux valgus horn and conservative treatment or surgical treatment is applied. If the deformation is large, surgical treatment is applied, but there is no operation method applicable to any kind of deformation and it is vital to treat hallux valgus before the deformation reaches an advanced stage.
In addition to the treatment by surgical operation, device treatment using a jig for the purpose of correcting hallux valgus is known. The device treatment includes an arch support (insole) used while walking and a correcting device.
For example, Patent Literature 1 discloses a preventive or correcting means for an open foot or the like by the arch support (insole). However, while the means disclosed in Patent Literature 1 is effective for pain, it is difficult for the means to correct deformation.
Patent Literatures 2 and 4, for example, disclose a correcting device with a supporter. Patent Literatures 5 and 6 disclose a correcting instrument made of a tubular body and a plate piece or elastic pad. Patent Literature 7 discloses a correcting instrument using a shape memory alloy that maintains an arch shape with a mesh made of Ti—Ni shape memory alloy wire.
Unfortunately, however, a conventional correcting device does not have a sufficient correcting force and a straightening effect thereof is not sufficient just by being attached as a splint, posing a problem that the correcting device is insufficient for treatment of hallux valgus or preventive treatment.
For example,
Further, for example, the Clinical Practice Guideline for Hallux Valgus (Hallux Valgus Guideline Drawing Committee of Clinical Practice Guideline Committee of the Japanese Orthopaedic Association) describes that “though a straightening effect of deformation of a slight degree can be expected when attached, whether the deformation is improved when not attached cannot be concluded” and thus, even today, there is currently no effective device treatment intended for correction.
Patent Literature 1: Japanese Patent Application Laid-Open No. 2005-13682
Patent Literature 2: Japanese Patent No. 3748996
Patent Literature 3: Japanese Patent Application Laid-Open No. 2001-29374
Patent Literature 4: Japanese Patent Application Laid-Open No. 2001-299792
Patent Literature 5: Japanese Patent No. 2964405
Patent Literature 6: Japanese Patent Application Laid-Open No. 2008-178436
Patent Literature 7: Japanese Patent Application Laid-Open No. 8-10278
The present invention has been made in view of the above problems and a subject thereof is to provide a device for correcting hallux valgus that can easily be attached and exerts a large correcting force to correct hallux that is deformed and valgus by using a shape memory alloy.
Features of the present invention as a means for solving the above subject include the following:
A device for correcting hallux valgus according to the present invention is a device for correcting hallux valgus that corrects hallux valgus, wherein a correcting plate formed of a shape memory alloy and an attachment member formed of a cloth-like body to attach the correcting plate are included and the correcting plate is attached to a body portion of a foot by a first attachment member and the body portion of the hallux by a second attachment member from a hallux inner side direction.
Further, in the device for correcting hallux valgus according to the present invention, the correcting plate is further attached to the body portion of the foot and the body portion of the hallux by the attachment member from the hallux inner side direction.
Further, in the device for correcting hallux valgus according to the present invention, the correcting plate is further attached to the body portion of the foot by the first attachment member and the body portion of the hallux by the second attachment member from the hallux inner side direction.
Further, in the device for correcting hallux valgus according to the present invention, the correcting plate further has an opening formed in a portion corresponding to a first metatarsophalangeal joint of the correcting plate and corrects the hallux by using a periphery of the opening as a supporting point.
Further, in the device for correcting hallux valgus according to the present invention, the correcting plate further has a pad made of a flexible material placed in the opening.
Further, in the device for correcting hallux valgus according to the present invention, the attachment member is further formed of an elastic body.
Further, in the device for correcting hallux valgus according to the present invention, the device for correcting hallux valgus further has a flat fixed plate in a portion of the hallux with a nail.
Further, in the device for correcting hallux valgus according to the present invention, the device for correcting hallux valgus has the correcting plate and the fixed plate integrated therein.
Further, in the device for correcting hallux valgus according to the present invention, the correcting plate used for the device for correcting hallux valgus is further a Cu—Al—Mn system shape memory alloy.
Further, in the device for correcting hallux valgus according to the present invention, the fixed plate used for the device for correcting hallux valgus is further a Cu—Al—Mn system shape memory alloy.
Further, in the device for correcting hallux valgus according to the present invention, the Cu—Al—Mn system shape memory alloy is formed of an alloy containing Al: 3 to 10% by mass, Mn: 5 to 20% by mass, and copper and inevitable impurities as a rest and to which one or two or more selected from Ni, Co, Fe, Ti, V, Cr, Si, Nb, Mo, W, Sn, Sb, Mg, P, Be, Zr, Zn, B, C, Ag, and misch metal may be added 0.001 to 10% by mass in total.
A method of producing a device for correcting hallux valgus according to the present invention is a method of producing a device for correcting hallux valgus that manufactures device for correcting hallux valgus having a correcting plate formed of a shape memory alloy and an attachment member formed of a cloth-like body to attach the correcting plate, wherein the correcting plate is a Cu—Al—Mn system shape memory alloy and is formed of an alloy containing Al: 3 to 10% by mass, Mn: 5 to 20% by mass, and copper and inevitable impurities as a rest and to which one or two or more selected from Ni, Co, Fe, Ti, V, Cr, Si, Nb, Mo, W, Sn, Sb, Mg, P, Be, Zr, Zn, B, C, Ag, and misch metal may be added 0.001 to 10% by mass in total.
Further, in the method of producing a device for correcting hallux valgus according to the present invention, the device for correcting hallux valgus further has a flat fixed plate in a portion of the hallux with a nail and the fixed plate is the Cu—Al—Mn system shape memory alloy and is formed of the alloy containing Al: 3 to 10% by mass, Mn: 5 to 20% by mass, and copper and inevitable impurities as a rest and to which one or two or more selected from Ni, Co, Fe, Ti, V, Cr, Si, Nb, Mo, W, Sn, Sb, Mg, P, Be, Zr, Zn, B, C, Ag, and misch metal may be added 0.001 to 10% by mass in total.
Further, in the method of producing a device for correcting hallux valgus according to the present invention, the Cu—Al—Mn system shape memory alloy is further formed by forming a plate material by cold rolling of a two-phase structure of α+β and, after the plate material being formed into a predetermined shape, by carrying out solution heat treatment in a temperature range of 700 to 950° C. in a time range of 0.01 to 1 hour and further, aging treatment in the temperature range of 50 to 250° C. in the time range of 0.1 to 1 hour.
Characteristic effects shown below are achieved by the present invention as a means for solving the above subject.
By virtue of a device for correcting hallux valgus according to the present invention, the device for correcting hallux valgus can easily be attached and correct hallux valgus or hallux varus with a large correcting force by using a shape memory alloy.
Further, by virtue of a method of producing a device for correcting hallux valgus according to the present invention, a device for correcting hallux valgus using a shape memory alloy that allows to be easily attached and exerts a large correcting force can easily be produced.
The best mode for carrying out the present invention will be described below based on the drawings. A so-called person skilled in the art can easily develop another embodiment by altering/modifying the present invention within the scope of claim, these alterations/modifications are contained within the scope of claim, and the description that follows is an example of the best mode in the present invention and does not limit the scope of claim.
A device for correcting hallux valgus 1 according to the present invention includes, as shown in
The correcting plate 11 of the device for correcting hallux valgus 1 according to the present invention is formed of a shape memory alloy. The shape memory alloy is an alloy having one or both of a shape memory effect, which is a property that even if the alloy is deformed at a predetermined temperature (As temperature) or lower, the original shape is restored if the alloy is heated to a predetermined temperature (Af temperature) or higher, and a superelastic effect, which is a property that even if the alloy is deformed at a predetermined temperature (Af temperature) or higher, the original shape is restored if unloaded. If the shape memory effect is used, a correcting force can be applied to hallux valgus 21 by heating. Particularly, deformation/restoration can be achieved by a fixed load or a small load change through the use of superelastic deformation and thus, it is preferable to use the superelastic effect. Therefore, when the hallux valgus 21 is corrected by attaching the correcting plate 11 whose Af temperature is set to the room temperature or lower to a person's foot 2, the hallux valgus 21 is corrected by a force acted on by the original shape being attempted to restore.
Shape memory alloys include a Cu—Al—Mn system, Cu—Zn—Al system, Ti—Mo—Sn system, and Ni—Ti system and an alloy of any system may be used.
As shown in
As shown in
If the foot 2 has the hallux valgus 21, as indicated by an arrow A, the hallux 21 is pressed toward the inner side due to pressure of worn shoes or the like and other toes of the foot 2 are likewise subject to a similar pressure. Then, a first metatarsophalangeal joint (joint) 26 of the foot 2 is conversely deformed like being pressed out to the outer side of the foot 2. Therefore, the device for correcting hallux valgus 1 according to the present invention attempts to restore the original state before the deformation.
If the device for correcting hallux valgus 1 using the correcting plate 11 as shown in
Further, though not illustrated, an elastic member is arranged in the attachment member 12 at the sole so that the height when shoes are worn is adjusted. Accordingly, the promotion of deformation of the foot 2 being corrected by raising the instep of the foot 2 can be prevented.
As shown in
As shown in
As shown in
As shown in
As shown in
As shown in
By changing the number of the correcting plates 11 inserted into the pocket 123 or the type thereof, the strength to pull the hallux 21 in the opposite direction can be adjusted.
If, as described above, the foot 2 has the hallux valgus 21, as indicated by an arrow A, the hallux 21 is pressed toward the inner side by the pressure of worn shoes or the like and other toes of the foot 2 are likewise subject to a similar pressure. Further, as shown in
The device for correcting hallux valgus 1 according to the present invention has, as shown in
The state exerted by the fixed plate 13 is shown as a perspective view of the foot 2 to which the fixed plate 13 is attached in
As shown in
The fixed plate 13 may be made of any hard material such as a plastic, resin, and metal. Instead of attaching the fixed plate 13, hard cloth may be fitted to a portion of the attachment member 12 to make the portion hard to use the attachment member 12 in place of the fixed plate 13.
The fixed plate 13 is attached by the attachment member 12 here, but may be integrated with the correcting plate 11 to create a shape memory alloy in a superelastic state. By creating a shape memory alloy in a superelastic state, a rotating force can be exerted on the hallux 21 when pressed even if the shape memory alloy is shifted from the attachment member 12. Further, a superelastic shape restoring force can be changed to a correcting force.
The fixed plate 13 may be a shape memory alloy in a martensite phase state. A shape memory alloy in a martensite phase state is flexible so that an appropriate shape in accordance with the shape of the foot can be provided.
The device for correcting hallux valgus 1 according to the present invention uses elastic rubber as the attachment member 12. The device for correcting hallux valgus 1 can be attached to the foot 2 easily and reliably by the rubber. Further, the correcting plate 11 can also be attached easily by providing a slit 124 in a portion of the rubber and inserting an end of the correcting plate 11 through the slit 124.
The rubber may be the integrated attachment member 12, but may be both or one of the first attachment member 121 and the second attachment member 122. Particularly, by using rubber for the second attachment member 122, the second attachment member 122 can easily be attached by inserting the tip of the hallux 21.
The device for correcting hallux valgus 1 according to the present invention uses a surface fastener 125 by adding to elastic bodies such as rubber of the first attachment member 121 and the second attachment member 122 as the attachment member 12. The device for correcting hallux valgus 1 can be attached to the foot 2 easily and reliably by the surface fastener 125.
The surface fastener 125 may be added to the attachment member 12 in which a cloth-like body is integrated or to both or one of the first attachment member 121 and the second attachment member 122 in which the cloth-like body is separated. Particularly, by using the surface fastener 125 for the second attachment member 122, the second attachment member 122 can be attached to a thin portion at the tip of the hallux 21 easily in a short time. Accordingly, a force acts in the direction of an arrow P to pull the hallux 21 to the inner side in the direction away from the foot 2 so that the foot 2 of the hallux valgus 21 can be corrected.
An ordinary metal is initially deformed elastically in accordance with the amount of change in bending and then enters a region of plastic deformation and is, as indicated by an arrow M1, deformed plastically. If the application of load is stopped before breakdown, as indicated by an arrow M2, the amount of change is not restored to the original amount of change as the load decreases, leaving the amount of change for plastic deformation.
In the superelastic effect of a shape memory alloy, by contrast, the alloy is initially deformed elastically in accordance with the amount of change in bending and then, as indicated by an arrow M3, the amount of change increases while the load remains almost constant without entering the region of plastic deformation. If the application of load is stopped before breakdown, as indicated by an arrow M4, the amount of change decreases while the load remains constant and the amount of change is restored to the original amount of change, leaving no amount of change for plastic deformation. The superelastic phenomenon acts as a load as a shape restoring force. Further, the load can be used as a correcting force of the hallux valgus 21 and hallux varus 21. Superelastic behavior in
A Cu—Al—Mn system alloy is used as the shape memory alloy. The Cu—Al—Mn system alloy is obtained at low cost, is highly processible, and can obtain a large correcting force. The Cu—Al—Mn system alloy includes an alloy in which Al is contained 3 to 10% by mass and Mn is contained 5 to 20% by mass and to which copper and a ternary system of impurities and if necessary, one or two or more selected from Ni, Co, Fe, Ti, V, Cr, Si, Nb, Mo, W, Sn, Sb, Mg, P, Be, Zr, Zn, B, C, Ag, and misch metal are added 0.001 to 10% by mass in total.
The Cu—Al—Mn system alloy having the shape memory effect and superelastic effect changes to a β-phase (b.c.c) single phase at high temperature and to a two-phase structure of β+α(f.c.c) at low temperature. 3% or more of Al is needed for the generation of the 13 single phase, but an excessive quantity of Al exceeding 10% makes the Cu—Al—Mn system alloy brittle. Preferably, the Al content is set to the range of 6 to 10%.
The addition of Mn enables the existence of the β phase on a low Al side and improves cold workability of the Cu—Al—Mn system alloy. Such an effect becomes conspicuous when 5% of Mn or more is contained, but excessive addition of Mn exceeding 20% adversely affects the shape memory effect or the superelastic effect by lowering the martensite transformation temperature. Preferably, the Mn content is set to the range of 8 to 12%.
As other addition ingredients, one or two or more selected from Ni, Co, Fe, Ti, V, Cr, Si, Nb, Mo, W, Sn, Sb, Mg, P, Be, Zr, Zn, B, C, Ag, and misch metal may be added 0.001 to 10% by mass in total.
Ni, Co, Fe, Sn, Sb, and Be produce an action of strengthening a matrix and Ti immobilizes N and O for detoxication. W, V, Nb, Mo, and Zr are components effective for improvement of hardness and abrasion resistance. Cr improves abrasion resistance and corrosion resistance, Si improves corrosion resistance, Mg improves hot workability and ductility, and P and misch metal are added as a deoxidizer and also contribute to ductility improvement. Zn raises the shape memory temperature, B and C strengthen the grain boundary to improve workability and ductility, and Ag contributes to improvement of cold workability. Therefore, a plate material is formed by cold rolling of a two-phase structure of α+β while performing process annealing in the temperature range of 500 to 700° C. and after the predetermined shape is formed, solution heat treatment at 700 to 950° C. in the time range of 0.01 to 1 hour and further, aging treatment at 50 to 250° C. in the time range of 0.1 to 1 hour are carried out.
A shape memory alloy has the shape memory effect that restores the original shape by heating and superelasticity that restores the original shape after unloading of stress and the Cu—Al—Mn system alloy preferably show superelasticity at room temperature.
The stress generally increases in an ordinary metal with an increasing deformation, but the rise in stress due to deformation is small in superelasticity and thus, a deforming force does not depend on the degree of deformation of the hallux valgus 21 much and a straightening force can be applied effortlessly.
If the Cu—Al—Mn system alloy is used as the raw material of the correcting plate 11, changes of the straightening force in accordance with environmental changes are small and thus, a stable straightening force is applied for a long period.
An alloy of the composition of Al: 8.1% by mass, Mn: 11.2% by mass, and Cu for the rest is produced by high-frequency induction fusion and a plate material is produced by casting in a mold, hot rolling at 600° C., and cold rolling while performing intermediate annealing at 600° C. The obtained plate is annealed at 600° C. for 10 min to form the plate into a predetermined shape. Further, solution heat treatment at 900° C. for five min, cold water, and aging treatment at 200° C. for 15 min are carried out before superelastic characteristics manifest themselves.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2010-006489 | Jan 2010 | JP | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/JP2010/060820 | 6/25/2010 | WO | 00 | 1/11/2013 |
