FIELD OF THE INVENTION

The invention relates to an orthotic device for treating defective positioning in the metatarsal and forefoot areas of the foot and more specifically to an orthotic device with a toe separator for stabilizing (anchoring) patient's toes in a predetermined position.

BACKGROUND OF THE INVENTION

Defective positioning, such as hallux valgus, hammer toes, or claw toes, sometimes occurs due to hereditary abnormalities and sometimes due to faulty footwear or overloading or malpositioning of the lower extremities. The explanations relating to hallux valgus are also applicable to other types of defective positioning in the metatarsal and forefoot area.

Hallux valgus is defined as an outward deviation of the big toe at the metatarsophalangeal joint. The term, "outward" here and in the following always indicates a direction away from the center plane of the body; specifically towards the small toe. Consequently, the term, "inward" is in the opposite direction, that is, from the small toe towards the big toe. In hallux valgus, the tendons of the toes no longer run centrally across the joint, but rather run further inward, and they pull the toes into a slanted position relative to each other. The ball of the big toe, which projects because of this slanted positioning, frequently suffers painful inflammation, caused by the pressure of the shoe in this area. At the same time, the angle between the various metatarsal bones is enlarged, especially between the metatarsal bone adjacent to the big toe and the proximal phalanx of the big toe. A frequent accompanying symptom is arthrosis. Among the causes of hallux valgus are splay foot, with the anterior transversal arch caving in and the big toe deviating as a result, and especially faulty footwear, which, due to fashion, is frequently worn in a size that is too small, has heels that are too high, or has a toe area that is too narrow.

US 8413349 discloses a corrective insole for treating defective positioning in the metatarsal and forefoot areas of the foot which includes an insole including at least two strap mechanisms a toe strap and a metatarsal strap such that the metatarsal strap encircles the metatarsal area of the foot to enable optimum correction of defective positioning associated with conditions such as hallux valgus.

Corrective treatment of the patient should be performed in the maximally comfortable conditions. The prior art analysis indicates a long-felt and unmet need of conformably anchoring of the patient's foot on a supporting insole in a predetermined position.

SUMMARY OF THE I VENTION

It is hence one object of the invention to disclose an orthotic device for treating defective positioning in metatarsal and forefoot areas. The aforesaid orthotic device comprises: (a) a support member configured for supporting a patient's foot at least in a forefoot area and (b) affixation means for conformably stabilizing (anchoring) patient's toes in a predetermined position.

It is a core purpose of the invention to provide the support member having a convex portion positionable at a distal side of metatarsal joints. The orthotic device further comprises: (a) a toe separator configured for positioning the patient's toes individually and (b) the support member having a convex portion positionable at a distal side of metatarsal joints and conformally adjacent thereto. The toe separator is integrally connected to the support member.

Another object of the invention is to disclose the supporting member comprising areas for supporting foot arch and heel areas.

A further object of the invention is to disclose the toe separator and top member which are integrally connected to the support member.

A further object of the invention is to disclose the toe separator which supports at least 50% of toe length. A further object of the invention is to disclose the support member having a recess for preventing a damaged area from a mechanical contact with the support member.

A further object of the invention is to disclose the heel area having a recess for preventing a calcaneal spur from a mechanical contact with the heel area.

A further object of the invention is to disclose the orthotic device comprising a protective shield covering at least one patient's toe in order to prevent at least one patient's toe from an uncontrolled contact with environment.

A further object of the invention is to disclose a method of manufacturing an orthotic device for treating defective positioning in metatarsal and forefoot areas. The method comprises the steps of: (a) imaging a patient's foot to be treated; (b) creating a digital model of the orthotic device comprising: (i) a support member configured for supporting a patient's foot at least in a forefoot area and (ii) affixation means for conformably anchoring patient's toes in a predetermined position; (c) 3D printing the orthotic device.

It is another purpose of the invention to provide the step of creating the digital model comprises creating: the support member having a convex portion positionable at a distal side of metatarsal joints and conformally adjacent thereto; and a toe separator configured for positioning the patient's toes individually. The toe separator is integrally connected to the support member.

A further object of the invention is to disclose an orthotic device for treating defective positioning in metatarsal and forefoot areas. The aforesaid orthotic device comprises: (a) a sock-shaped flexible article drawable onto a patient's foot; the sock-shaped flexible article comprising a toe separator having individual openings configured for receiving patient's toes for conformably stabilizing (anchoring) patient's toes in a predetermined position; (b) a soft support member configured for supporting a patient's foot at least in a forefoot area and (c) a rigid support member configured for supporting a patient's foot at least in a forefoot area; the rigid support member being conformal to the patient's foot.

A further object of the invention is to disclose a method of manufacturing an orthotic device for treating defective positioning in metatarsal and forefoot areas. The aforesaid method comprises the steps of: (a) imaging a patient's foot to be treated; (b) creating a digital model of the orthotic device comprising: (i) a support member configured for supporting a patient's foot at least in a forefoot area and (ii) affixation means for conformably stabilizing (anchoring) patient's toes in a predetermined position; (c) 3D printing the orthotic device.

The step of creating the digital model comprises creating: a sock-shaped flexible article drawable onto a patient's foot; the sock-shaped flexible article comprising a toe separator having individual openings configured for receiving patient's toes for conformably anchoring patient's toes in a predetermined position; a soft support member configured for supporting a patient's foot at least in a forefoot area and a rigid support member configured for supporting a patient's foot at least in a forefoot area; the rigid support member being conformal to the patient's foot.

A further object of the invention is to disclose a non-transitory computer readable medium storing a program causing a computer to execute steps of: (a) imaging a patient's foot to be treated; (b) creating a digital model of the orthotic device comprising: (i) a support member configured for supporting a patient's foot at least in a forefoot area and (ii) affixation means for conformably stabilizing (anchoring) patient's toes in a predetermined position; (b) 3D printing the orthotic device.

It is another purpose of the invention to provide the step of creating the digital model comprising creating: the support member having a convex portion positionable at a distal side of metatarsal joints and conformally adjacent thereto; and a toe separator configured for positioning the patient's toes individually; the toe separator is integrally connected to the support member.

A further object of the invention is to disclose the step of creating the digital model comprising creating: a sock-shaped flexible article drawable onto a patient's foot; the sock-shaped flexible article comprising a toe separator having individual openings configured for receiving patient's toes for conformably stabilizing (anchoring) patient's toes in a predetermined position; a soft support member configured for supporting a patient's foot at least in a forefoot area and a rigid support member configured for supporting a patient's foot at least in a forefoot area; the rigid support member being conformal to the patient's foot. A further object of the invention is to disclose an orthopedic shoe for treating defective positioning in metatarsal and forefoot areas. The aforesaid shoe comprises (a) a sock- shaped flexible article drawable onto a patient's foot before the orthopedic shoe is put on; the sock-shaped flexible article comprising a toe separator having individual openings configured for receiving patient's toes for conformably anchoring patient's toes in a predetermined position; (b) a rigid support member integrally arranged with orthopedic shoe ; the orthopedic shoe configured for supporting a patient's foot at least in a forefoot area; the rigid support member being conformal to the patient's foot; (c) a soft support member placeable between the sock-shaped flexible article and rigid support member; the soft support member configured for supporting a patient's foot at least in a forefoot area.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments is adapted to now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which

Figs la and lb are an anatomically referred schematic view of an orthotic device for treating defective positioning in metatarsal and forefoot areas and a top photograph thereof, respectively;

Fig. 2 is a photograph of an orthotic device;

Fig. 3 is a photograph of an orthotic device with a recess in a heel area thereof;

Fig. 4 is a photograph of an orthotic device with a recess in a foot-arch area thereof;

Fig. 5 is a photograph of an orthotic device for supporting a forefoot area of a patient's foot;

Fig. 6 is a photograph of an orthotic device for supporting forefoot and foot-arch areas of a patient's foot; Fig. 7 is a photograph of an orthotic device provided with a top member which partially embraces a forefoot area;

Fig. 8 is a photograph of an orthotic device provided with a protective shield;

Fig. 9a is a perspective view of an orthotic device put on a patient's foot;

Fig. 9b is an explosive perspective view of an orthotic device; and

Fig. 10 illustrates producing a rigid support member using a mold.

Fig. 11 is a photograph of an orthotic device provided with a protective shield.

Fig. 12 is a photograph of an orthotic device provided with a metatarsal cushioning underneath the metatarsals, a cushioning underneath the heel area and a side protective shield.

Fig. 13 is a photograph of an orthotic device provided with a side protective shield.

Fig. 14 is a photograph of an orthotic device attached to a sheet and provided with a side protective shield.

Fig. 15 is a photograph of an orthotic device attached to a sheet and provided with a cushioning underneath the arc area.

Fig. 16 is a photograph of an orthotic device provided with a top member for comfortably wearing the orthotic device as a flipflop.

DETAILED DESCRIPTION OF THE INVENTION

The following description is provided, so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, are adapted to remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide an orthotic device for treating defective positioning in metatarsal and forefoot areas and a method of manufacturing thereof. Reference is now made to Figs la and lb, presenting a concept of the present invention. Specifically, a forefoot (metatarsal joints) of the patient is supported by member C from below. The patient's toes are separated by separator ^. According to one embodiment of the present invention, toe separator ^ supports at least 50% of toe length. Convex portion B is positionable at a distal side of metatarsal joints. Toe separator A is integrally connected to the support member. The therapeutic effect is achieved by correction of toes' position defined by the elements A and B. Convex portion B is conformally adjacent to the distal side of metatarsal joints.

Reference is now made to Fig. 2 presenting an orthotic device for treating defective positioning in metatarsal and forefoot areas. The device comprises support member 10 provided with separator 20 and top member 30. The disclosed orthotic device is applicable for treatment of hallux valgus, Metatarsalgia, Claw toes, Hammertoes and deformed toes and similar pathological conditions.

It should be mentioned that the orthotic device of the present invention can be manufactured in a form completely conformal to the patient's foot. According to another aspect of the present invention, the patient's foot is imaged and digitized. At the next step, a digital model of the patient's foot is created. The orthotic article is made by a 3D printer is a completely conformal manner.

Reference is now made to Fig. 3, presenting the orthotic device comprising an insole having forefoot, foot-arch and heel areas 10a, 10b and 10c, respectively. Heel area 10c is provided with recess 15 which prevents a calcaneal spur in the patient's foot (not shown) from a mechanical contact with the heel area.

Reference is now made to Fig. 4, showing the orthotic device having forefoot and foot- arch areas 10a and 10b, respectively. Member 30 embraces the metatarsal area of the patient's foot. Recess 18 is configured for preventing a damaged area of the patient's foot from a mechanical contact with the device in order to avoid an additional trauma.

Reference is now made to Figs 5 and 6, presenting alternative embodiments of the present invention. Specifically, Fig. 5 shows an embodiment comprising forefoot area 10a only, while, in Fig. 6, forefoot and foot-arch areas 10a and 10b support the patient's foot (not shown). Reference is now made to Fig. 7, presenting a further embodiment of the present invention. Top member 30a partially embraces the metatarsal area of the patient's foot (not shown).

Reference is now made to Fig. 8, presenting a presenting a further embodiment of the present invention provided with protective shield 25 preventing a hammer toe (not shown) from an uncontrolled contact with the environment.

Reference is now made to Figs 9a and 9b presenting an orthotic device 90 for treating defective positioning in metatarsal and forefoot areas. The aforesaid orthotic device comprises sock-shaped flexible article 110, soft support member 120 and rigid support member 130. Sock-shaped flexible article 110 is drawable onto patient's foot 100. Sock- shaped flexible article 110 comprises toe separator 115 having individual openings configured for receiving patient's toes for conformably anchoring patient's toes in a predetermined position. Soft support member 120 is configured for supporting a patient's foot at least in a forefoot area. Rigid support member 130 is configured for supporting patient's foot 100 at least in a forefoot area. Rigid support member 130 is conformal to said patient's foot. Soft support member 120 (for example, made of a silicon material) is placeable between sock-shaped flexible article 110 and rigid support member 130 in order to unify the load over the area mechanical contact between patient's foot 100 and rigid support member 130 via sock-shaped flexible article 110.

Reference is now made to Fig. 10, illustrating a method of manufacturing an orthotic device for treating defective positioning in metatarsal and forefoot areas. Rigid support member 140 embeddable into an orthopedic shoe (not shown) is formed in conformity with mold 150.

Reference is now made to Fig. 11, presenting a further embodiment of the present invention showing the orthotic device having a metatarsal cushioning underneath the metatarsals A and B and having a cushioning underneath the heel area C and a side protective shield D.

Reference is now made to Fig. 12, presenting a further embodiment of the present invention showing the orthotic device having a side protective shield A. Reference is now made to Fig. 13, presenting a further embodiment of the present invention showing the orthotic device attached to a sheet for minimizing wear and tear A and a side protective shield B.

Reference is now made to Fig. 14, presenting a further embodiment of the present invention showing the orthotic device attached to a sheet for minimizing wear and tear A and having a cushioning underneath the arc area B.

Reference is now made to Fig. 15, presenting a further embodiment of the present invention showing the orthotic device having a top member for comfortably wearing the orthotic device as a flipflop A.

According to the present invention, a patient's foot to be treated is imaged. On the basis of the obtained patient's foot image, a digital model of said orthotic device is created. The mold is made by 3D printing.

According to the present invention, an orthotic device for treating defective positioning in metatarsal and forefoot areas is disclosed. The aforesaid orthotic device comprises: (a) a support member configured for supporting a patient's foot at least in a forefoot area and (b) affixation means for conformably stabilizing (anchoring) patient's toes in a predetermined position.

It is a core feature of the invention to provide the support member having a convex portion positionable at a distal side of metatarsal joints and conformally adjacent thereto. The affixation means comprises a toe separator configured for positioning the patient's toes individually. The toe separator is integrally connected to the support member.

According to one embodiment of the present invention, the supporting member comprises areas for supporting foot arch and heel areas.

According to another embodiment of the present invention, the toe separator and top member are integrally connected to the support member.

According to a further embodiment of the present invention, the toe separator supports at least 50% of toe length. According to a further embodiment of the present invention, the support member has a recess for preventing a damaged area from a mechanical contact with the support member.

According to a further embodiment of the present invention, the heel area has a recess for preventing a calcaneal spur from a mechanical contact with the heel area.

According to a further embodiment of the present invention, the orthotic device comprises a protective shield covering at least one patient's toe in order to prevent at least one patient's toe from an uncontrolled contact with environment.

According to a further embodiment of the present invention, a method of manufacturing an orthotic device for treating defective positioning in metatarsal and forefoot areas is disclosed. The method comprises the steps of: (a) imaging a patient's foot to be treated;

(b) creating a digital model of the orthotic device comprising: (i) a support member configured for supporting a patient's foot at least in a forefoot area and (ii) affixation means for conformably stabilizing (anchoring) patient's toes in a predetermined position;

(c) 3D printing the orthotic device.

It is another purpose of the invention to provide the step of creating the digital model comprises creating: the support member having a convex portion positionable at a distal side of metatarsal joints and conformally adjacent thereto; and a toe separator configured for positioning the patient's toes individually. The toe separator is integrally connected to the support member.

According to a further embodiment of the present invention, an orthotic device for treating defective positioning in metatarsal and forefoot areas is disclosed. The aforesaid orthotic device comprises: (a) a sock-shaped flexible article drawable onto a patient's foot; the sock-shaped flexible article comprising a toe separator having individual openings configured for receiving patient's toes for conformably stabilizing (anchoring) patient's toes in a predetermined position; (b) a soft support member configured for supporting a patient's foot at least in a forefoot area and (c) a rigid support member configured for supporting a patient's foot at least in a forefoot area; the rigid support member being conformal to the patient's foot. According to a further embodiment of the present invention, a method of manufacturing an orthotic device for treating defective positioning in metatarsal and forefoot areas is disclosed. The aforesaid method comprises the steps of: (a) imaging a patient's foot to be treated; (b) creating a digital model of the orthotic device comprising: (i) a support member configured for supporting a patient's foot at least in a forefoot area and (ii) affixation means for conformably stabilizing (anchoring) patient's toes in a predetermined position; (c) 3D printing the orthotic device.

The step of creating the digital model comprises creating: a sock-shaped flexible article drawable onto a patient's foot; the sock-shaped flexible article comprising a toe separator having individual openings configured for receiving patient's toes for conformably anchoring patient's toes in a predetermined position; a soft support member configured for supporting a patient's foot at least in a forefoot area and a rigid support member configured for supporting a patient's foot at least in a forefoot area; the rigid support member being conformal to the patient's foot.

According to a further embodiment of the present invention, a non-transitory computer readable medium storing a program causes a computer to execute steps of: (a) imaging a patient's foot to be treated; (b) creating a digital model of the orthotic device comprising: (i) a support member configured for supporting a patient's foot at least in a forefoot area and (ii) affixation means for conformably stabilizing (anchoring) patient's toes in a predetermined position; (b) 3D printing the orthotic device.

It is another feature of the invention to provide the step of creating the digital model comprising creating: the support member having a convex portion positionable at a distal side of metatarsal joints and conformally adjacent thereto; and a toe separator configured for positioning the patient's toes individually; the toe separator is integrally connected to the support member.

According to a further embodiment of the present invention, the step of creating the digital model comprises creating: a sock-shaped flexible article drawable onto a patient's foot; the sock-shaped flexible article comprising a toe separator having individual openings configured for receiving patient's toes for conformably stabilizing (anchoring) patient's toes in a predetermined position; a soft support member configured for supporting a patient's foot at least in a forefoot area and a rigid support member configured for supporting a patient's foot at least in a forefoot area; the rigid support member being conformal to the patient's foot.

According to a further embodiment of the present invention, an orthopedic shoe for treating defective positioning in metatarsal and forefoot areas is disclosed. The aforesaid shoe comprises (a) a sock-shaped flexible article drawable onto a patient's foot before the orthopedic shoe is put on; the sock-shaped flexible article comprising a toe separator having individual openings configured for receiving patient's toes for conformably anchoring patient's toes in a predetermined position; (b) a rigid support member integrally arranged with orthopedic shoe; the orthopedic shoe configured for supporting a patient's foot at least in a forefoot area; the rigid support member being conformal to the patient's foot; (c) a soft support member placeable between the sock-shaped flexible article and rigid support member; the soft support member configured for supporting a patient's foot at least in a forefoot area.