(19)
(11)EP 2 163 227 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
29.08.2012 Bulletin 2012/35

(21)Application number: 09170362.9

(22)Date of filing:  15.09.2009
(51)Int. Cl.: 
A61F 5/01  (2006.01)

(54)

Foot abduction bracing apparatus

Spreizvorrichtung zur Fußabduktion

Appareil de calage du pied en abduction


(84)Designated Contracting States:
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK SM TR

(30)Priority: 16.09.2008 US 211658

(43)Date of publication of application:
17.03.2010 Bulletin 2010/11

(73)Proprietor: Mitchell, John R.
Wayland IA 52654 (US)

(72)Inventor:
  • Mitchell, John R.
    Wayland IA 52654 (US)

(74)Representative: Tansini, Elio Fabrizio et al
Bugnion S.p.A. Viale Lancetti, 17
20158 Milano
20158 Milano (IT)


(56)References cited: : 
DE-U1- 20 212 504
US-B1- 7 267 657
US-A1- 2007 073 206
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    BACKGROUND OF THE INVENTION



    [0001] Dr. Ignacio Ponseti is an internationally famous physician and surgeon specializing in the treatment and management of a childhood deformity commonly know as a club foot. Dr. Ponseti has for many decades promoted the use of a foot and ankle abduction device, or orthosis, that is used to correct and prevent relapses of the club foot deformity. These abduction devices typically consist of a rigid bar connected between shoes worn by the child which bar separates the feet of the child and holds the feet in an outward rotation or abduction. Typically, if the condition is diagnosed early enough, this device is worn full-time for a period of months, but during the period of treatment, the angle of outward rotation is periodically adjusted.

    [0002] The Ponseti technique, as it has become known throughout the world, has been highly successful in treating club feet without the necessity of corrective surgery. Many devices have been designed and used for many many years in applying the Ponseti technique. Currently used devices that apply the Ponseti technique are shown in U.S. Patent No. 7,267,657. In this patent, there are disclosed improvements in such devices which provide for quick release of the shoes from the abduction bar and which also provide a method for varying the abduction angle and locking it in place at a selected angle. Devices of this type have been extremely successful and are widely used by those who treat patients using the Ponseti technique. However, the devices are relatively expensive, and in many countries throughout the world, the cost prohibits widespread usage.

    [0003] It is also known from DE 20212504 U1 an abduction bar made of a manually deformable metallic material which has, at its ends, connecting plates each being fixed to a respective shoe. The bar can be deformed in order to provide variation of the relative angle between the shoes.

    [0004] Moreover, US 2007/0073206 discloses a quick-release mechanism for disconnecting the footwear and footplate of an orthoses from a rotation bar. The mechanism includes connecting plates which are connectable to the lower surface of footplates, the connecting plates being linked in a pivotable manner to a rigid connecting bar.

    [0005] There is therefore a need for an improved but yet relatively inexpensive orthosis for use in treating club feet using the Ponseti technique.

    SUMMARY OF THE INVENTION



    [0006] The improved foot abduction brace device of the invention is a relatively simple device in which the shoe and abduction bar are connected by a simple fastening device such as a set screw, and in which the abduction bar is a single bar that can be bent by the treating physician to hold the shoes in the desired degrees of abduction and dorsiflexion. The abduction bar is bent near the heel portion of the shoe and is made of a material that allows the bar to retain the selected position once bent. However, the bar must be sufficiently strong so that the child cannot bend the bar and therefore change the abduction angle.

    BRIEF DESCRIPTION OF THE DRAWING



    [0007] 

    FIG. 1 is a perspective view generally from the side of the shoe and showing the one-piece shoe and bar connected;

    FIG. 2 is a perspective view from a slightly different angle than that of Fig.1 and showing the one-piece molded foot plate and bar connected;

    FIG. 3 is a perspective view showing the abduction bar in a selected position;

    FIG. 4 is a perspective view generally from the bottom of the shoe and showing one embodiment of the shoe that is adapted to be attached to the bar of Fig. 3;

    FIG. 5 is a rear view of the shoe of Fig. 4;

    FIG. 6 is a front view of the shoe of Fig. 4;

    FIG. 7 is a perspective view generally from the side showing another embodiment of the shoe;

    FIG. 8 is a front view of the shoe of Fig. 7; and

    FIG. 9 is a rear view of the shoe of Fig. 7.


    DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION



    [0008] Referring first to Fig. 1, there is illustrated a device constructed according to the principles of the invention and employing a shoe 10 that incorporates in the shoe a separate foot plate 12 to form a one-piece device. The shoe 10, sometimes referred to as a "gauntlet," is preferably made of a polyurethane-based compound or a polymer, a thermal molded material, or rubber -- all of which are strong elastic synthetic substances. The shoe 10 includes an upper strap 14, a middle strap 16, and a lower strap 18 on each side of the shoe 10. The straps on each side of the shoe 10 are connected across the foot and ankle of the patient in any suitable manner such as by laces (not shown) that extend through the openings 20 in the straps 14,16 and 18. A hole 21 is preferably formed on each side of the shoe 10 near the heel portion so as to check to make certain the heel of the patient is in the correct place down and back. In the embodiment of Fig. 1, the foot plate 12 is molded into the shoe 10 in any suitable manner to form the single structure. The foot plate 12 is formed of a material that provides rigidity to the device, and is formed preferably of urethane or thermal molded plastic. The foot plate 12 includes a slot 24 for receiving one end of the abduction bar 26. Once the abduction bar 26 is inserted into the slot 24, it is held in place by a suitable fastening member such as set screw 28 threaded into an opening 30 formed in the side of the foot plate 12. Although not shown in the drawings, it will be obvious to those skilled in the art that the other end of the abduction bar 26 is inserted into the other of the pair of shoes 10. The abduction bar 26 is preferably formed from an aluminum alloy or other suitable metal or composite material that has the properties which allow it to be bent into selected positions and retain in its memory the degree to which the bar is bent. The material of the abduction bar 26 must also have sufficient strength so that the child cannot bend the bar once it has bent into the desired abduction position by the therapist or physician. The abduction bar 26 is constructed so that it can hold the pair of shoes 10 in the desired degree of abduction, usually between 60° and 70° and 10-15° of dorsiflexion. The material of the abduction bar 26 allows the position of both shoes to be changed to more or less abduction or more or less dorsiflexion by bending the bar near the heel portion of the shoe 10. This allows the abduction bar 26 to be bent to various positions to change the abduction or dorsiflexion throughout the period of treatment of the patient. This is done in a very simple manner and thus greatly reduces the cost of this type of appliance used in the application of the Ponseti method.

    [0009] Referring now to Figs. 4, 5 and 6, there is shown another embodiment of the foot abduction brace device with Figs. 4, 5 and 6 showing the shoe 10 as a separate component from the foot plate 12. In other words, the shoe shown in Figs. 4, 5 and 6 is attached in any suitable manner to inside surface of the foot plate 12 of Fig. 2. Attachment of the shoe 10 to the foot plate 12 can be done in any suitable manner such as by use of a suitable adhesive. This embodiment of Figs. 4, 5 and 6 may be useful for applications in which the manufacturer of the abduction brace device as a molded one-piece shown in Fig. 1 is not practical or cost effective. In all other respects, the design of the shoe 10 in Figs. 4, 5 and 6 is identical to that described with reference to the one-piece structure of Fig. 1.

    [0010] Referring now to Figs. 7, 8 and 9, there is shown another embodiment of the shoe portion of the foot abduction brace device of the invention. In this embodiment, the shoe 10 and foot plate (not shown separately in this embodiment) are formed in a single molded process in which the sole portion 32 is molded to be sufficiently stiff to receive the abduction bar 26. Also, the embodiment of the shoe 10 in Figs. 7, 8 and 9 does not have separate straps but rather a continuous upper portion containing holes 22 to receive suitable laces or other fastening means. This embodiment of Figs. 7, 8 and 9 also contains an additional hole 34 which relieves pressure and therefore minimizes the possibility of blisters forming on the patient's foot and ankle at this pressure point. In all other respects, the shoe shown in this embodiment functions in the same manner as the other embodiments of the invention.

    [0011] Having described various embodiments of the invention, it will be obvious to those skilled in the art that the foot abduction brace device of this invention is a very simple and therefore less costly version of an abduction brace device that can be used in applying the Ponseti method. The device of the invention therefore will have application for use in areas, such as third world countries, where the need is great but funds are not available to supply the more sophisticated designs of this type of device.


    Claims

    1. A foot abduction apparatus for maintaining a patient's feet in a predetermined therapeutic arrangement, the apparatus comprising:

    a rigid elongated abduction member (26) having a left end and a right end;

    a right shoe (10) operatively combined with the right end of the elongated member (26);

    a left shoe (10) operatively combined with the left end of the elongated member (26);

    the right and left shoes (10) each comprised of an upper portion for securing the shoe to the patient's foot and ankle and a foot plate (12);

    the foot plate (12) of each shoe (10) having a slot (24) formed therein to receive an end of the abduction member (26);

    a fastener combined with each shoe (10) and an end of the abduction member (26) to removably secure the abduction member (26) to the shoes (10), said fastener being a set screw (28); and

    the shoes (10) being made of a strong elastic material to secure them to the feet of the patient and the abduction member (26) being made of a suitable material that allows the member (26) to be bent so as to place the patient's feet at desired angles of abduction and dorsiflexion, wherein the angles can be periodically adjusted,

    characterized in that, once the abduction bar (26) is inserted into the slot (24), it is held in place by said set screw (28) threaded into an opening_(30) formed in the side of the foot plate (12).
     
    2. The foot abduction apparatus of claim 1 in which the upper portion of each shoe (10) is provided with a plurality of holes (22) and laces are woven through the holes (22) to secure the shoe (10) to the patient's foot.
     
    3. The foot abduction apparatus of claim 1 in which the foot plate (12) of each shoe (10) is formed of a material that provides rigidity to the shoe (10).
     
    4. The foot abduction apparatus of claim 3 in which the material is a thermal molded plastic substance.
     
    5. The foot abduction apparatus of claim 4 in which the foot plate (12) and upper portion of each shoe (10) are one piece.
     
    6. The foot abduction apparatus of claim 4 in which the foot plate (12) and upper portion of each shoe (10) are one piece and are formed by a single molded process.
     
    7. The foot abduction apparatus of claim 4 in which the foot plate (12) and upper portion of each shoe (10) are separate components.
     
    8. The foot abduction apparatus of claim 1 in which the upper portion of each shoe (10) is provided with one or more openings (34) to relieve pressure on the patient's foot and ankle.
     


    Ansprüche

    1. Fußabduktionsvorrichtung zum Halten der Füße eines Patienten in einer vorbestimmten therapeutischen Ausrichtung, umfassend:

    ein starres längliches Abduktionselement (26) mit einem linken und einem rechten Ende;

    einen rechten mit dem rechten Ende des länglichen Elements (26) wirkverbundenen Schuh (10);

    einen linken mit dem linken Ende des länglichen Elements (26) wirkverbundenen Schuh (10);

    wobei der rechte und der linke Schuh (10) je aus einem oberen Abschnitt zum Sichern des Schuhs am Patientenfuß und Patientenknöchel sowie aus einer Fußplatte (12) zusammengesetzt sind;

    wobei die Fußplatte (12) jeden Schuhs (10) einen darin ausgebildeten Schlitz (24) zur Aufnahme eines Endes des Abduktionselements (26) aufweist;

    ein mit je einem Schuh (10) und einem Ende des Abduktionselements (26) verbundenes Befestigungsorgan, um das Abduktionselement (26) an den Schuhen (10) lösbar zu befestigen, wobei solches Befestigungsorgan eine Feststellschraube (28) ist; und

    wobei die Schuhe (10) aus einem festen elastischen Material zum Sichern derselben an den Patientenfüßen gefertigt sind und das Abduktionselement (26) aus einem entsprechendem Material besteht, das erlaubt, dass das Element (26) derart gebogen wird, dass die Patientenfüße unter den gewünschten Abduktions- und Dorsalbeugungswinkeln ausgerichtet werden, wobei diese Winkel periodisch angepasst werden können;

    dadurch gekennzeichnet, dass nach Einstecken des Abduktionsstabs (26) in den Schlitz (24) dieser von der genannten Feststellschraube (28) lagefixiert wird, die in einer seitlich an der Fußplatte (12) ausgesparten Öffnung (30) angeschraubt wird.
     
    2. Fußabduktionsvorrichtung nach Anspruch 1, wobei der obere Abschnitt jeden Schuhs (10) mit mehreren Löchern (22) und Schnürsenkeln versehen ist und Schnürbänder durch die Löcher (22) hindurch geflochten sind, um den Schuh (10) am Patientenfuß zu sichern.
     
    3. Fußabduktionsvorrichtung nach Anspruch 1, wobei die Fußplatte (12) jeden Schuhs (10) aus einem Material besteht, das dem Schuh (10) Steifigkeit verleiht.
     
    4. Fußabduktionsvorrichtung nach Anspruch 3, wobei das Material ein thermogeformter Kunststoff ist.
     
    5. Fußabduktionsvorrichtung nach Anspruch 4, wobei die Fußplatte (12) und der obere Abschnitt (10) jeden Schuhs einteilig sind.
     
    6. Fußabduktionsvorrichtung nach Anspruch 4, wobei die Fußplatte (12) und der obere Abschnitt jeden Schuhs (10) einteilig sind und durch ein einziges Formgebungsverfahren gefertigt werden.
     
    7. Fußabduktionsvorrichtung nach Anspruch 4, wobei die Fußplatte (12) und der obere Abschnitt jeden Schuhs (10) getrennte Bauteile sind.
     
    8. Fußabduktionsvorrichtung nach Anspruch 1, wobei der obere Abschnitt jeden Schuhs (10) mit einer bzw. mehreren Öffnung(en) (34) versehen ist, um den Druck auf den Patientenfuß und Patientenknöchel leichter zu machen.
     


    Revendications

    1. Appareil d'abduction du pied pour maintenir les pieds d'un patient dans une disposition thérapeutique prédéterminée, l'appareil comprenant:

    - un élément d'abduction allongé rigide (26) ayant une extrémité gauche et une extrémité droite;

    - une chaussure droite (10) combinée de manière opérante avec l'extrémité droite de l'élément allongé (26) ;

    - une chaussure gauche (10) combinée de manière opérante avec l'extrémité gauche de l'élément allongé (26) ;

    - les chaussures droite et gauche (10) comprenant chacune une portion supérieure pour fixer la chaussure au pied et à la cheville du patient et une plaque ou sole pour le pied (12);

    - la plaque pour le pied (12) de chaque chaussure (10) ayant une fente (24) formée dans celle-ci pour recevoir une extrémité de l'élément d'abduction (26);

    - un élément de fixation combiné avec chaque chaussure (10) et une extrémité de l'élément d'abduction (26) pour fixer de manière amovible l'élément d'abduction (26) aux chaussures (10), ledit élément de fixation étant une vis de pression (28); et

    - les chaussures (10) étant fabriquées en une matière élastique résistante pour les fixer aux pieds du patient et l'élément d'abduction (26) étant fabriqué en une matière convenable permettant à l'élément (26) d'être plié et fléchi pour mettre les pieds du patient à des angles désirés d'abduction et dorsiflexion, où les angle peuvent être réglés périodiquement,

    caractérisé en ce que, une fois la barre d'abduction (26) est insérée dans la fente (24), elle est retenue en position par ladite vis de pression (28) vissée dans une ouverture (30) formée dans le côté de la plaque pour le pied (12).
     
    2. Appareil d'abduction du pied de la revendication 1, dans lequel la portion supérieure de chaque chaussure (10) est munie d'une pluralité de trous (22) et des lacets sont introduits à travers les trous (22) pour fixer la chaussure (10) au pied du patient.
     
    3. Appareil d'abduction du pied de la revendication 1, dans lequel la plaque pour le pied (12) de chaque chaussure (10) est fabriquée en une matière fournissant rigidité à la chaussure (10).
     
    4. Appareil d'abduction du pied de la revendication 3, dans lequel la matière est une substance plastique moulée à chaud.
     
    5. Appareil d'abduction du pied de la revendication 4, dans lequel la plaque pour le pied (12) et la portion supérieure de chaque chaussure (10) sont d'un seul tenant.
     
    6. Appareil d'abduction du pied de la revendication 4, dans lequel la plaque pour le pied (12) et la portion supérieure de chaque chaussure (10) sont d'un seul tenant et sont formées par un procédé de moulage unique.
     
    7. Appareil d'abduction du pied de la revendication 4, dans lequel la plaque pour le pied (12) et la portion supérieure de chaque chaussure (10) sont des éléments composants séparés.
     
    8. Appareil d'abduction du pied de la revendication 1, dans lequel la portion supérieure de chaque chaussure (10) est munie d'une ou de plusieurs ouvertures (34) pour alléger la pression sur le pied et la cheville du patient.
     




    Drawing












    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description