Abstract:
A device for the treatment of the body of a wearer comprising an orthopedic brace combined with at least one electrically active zone to stimulate the body of the wearer of the brace.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. application Ser. No. 12/865,988, filed Mar. 31, 2011, which is a national stage filing under 35 U.S.C. §371 of International Application No. PCT/IB2009/050460, filed Feb. 5, 2009, which claims the benefit of European Application No. 08151073.7, filed Feb. 5, 2008, the contents of which are incorporated by reference in their entirety. International Application No. PCT/IB2009/050460 was published under PCT Article 21(2) in English. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention concerns a stimulation brace. In particular, the present invention concerns a brace that is capable of carrying out an electrical stimulation of the body part on which the brace is used. 
       BACKGROUND ART 
       [0003]    Brace are well known per se in the art. An orthopaedic brace (also orthosis or orthotic) as commonly defined in the art is a device used to:
       immobilize a joint or body segment,   restrict movement in a given direction,   assist movement,   reduce weight-bearing forces, or   correct the shape of the body.       
 
         [0009]    Usually, the last purpose listed above is what persons call in common speech a brace, whether it is made from elastic neoprene or a stiffer, more restrictive construction such as hard plastic or metal. An orthotic is most often understood to be a somewhat flexible device, often an insert for shoes, to correct leg length, fallen arches (flat feet), or some other foot problem. 
         [0010]    Often the older type of leg brace is meant, constructed of steel side bars and ring, with spurs which fit into a metal tube in the heel of an adapted shoe or boot, and with straps and bands around the leg to hold the splint in position. The straps can be secured with VELCRO™ but many patients prefer buckles. This type of braces can either be non-weight relieving or, by slight lengthening, made to relieve weight by raising the heel of the foot away from the heel of the shoe or boot. These splints have to be individually made by an orthotist or appliance maker in order to closely fit the particular contours of the leg being supported. Of course, other types of braces are known which are used on other body parts. 
         [0011]    On the other hand, the electrical stimulation of the body is a technique that is also well known in the art for example for stimulation, pain management, edema reduction, muscle or vascular rehabilitation, bone growth stimulation etc. This technique usually implies the use of electrically active zones, for examples electrodes, linked to a stimulator (portable or not) that contains a stimulation program to be applied to a person (i.e. body part for example). 
         [0012]    In a further technology development, one has started to combine the use of a brace with electrodes. A typical example of such a device is given in U.S. Pat. No. 3,911,910 which discloses an electro-splint for relieving involuntary muscular spasticity. More specifically, this device comprises a splint structure for attachment to a body limb combined with skin attachable electrodes for attachment to skin zones overlying the trigger points of body muscle that control angular displacement of the associated limb portion. 
         [0013]    Other prior art in the field includes the following publications: WO 94/28966, U.S. Pat. No. 5,397,338, WO 96/18364, U.S. Pat. No. 5,628,722, U.S. Pat. No. 5,766,236, WO 98/43560, US2002/0032475, WO 02/060311, U.S. Pat. No. 6,607,500, US 2004/0243196, U.S. Pat. No. 4,586,495, EP 0 302 148, U.S. Pat. No. 4,697,808, U.S. Pat. No. 4,796,631, U.S. Pat. No. 5,121,747, EP 0 506 398, U.S. Pat. No. 5,476,441, EP 1 136 096, WO 02/092164, U.S. Pat. No. 7,162,305, US 2007/0112394, WO 2007/057899, WO 2007/093941, US 2007/197946, GB 2 426 930, WO 02/092164, WO2005/007029, WO 01/03768, JP 2002 200104, JP 2002 191707 and U.S. Pat. No. 5,628,722. 
         [0014]    In the specific field of bone growth and stimulation, the following publications can be considered as background: U.S. Pat. No. 4,889,111, EP 0 553 517, U.S. Pat. No. 5,330,477 and WO 03/024371. 
       SUMMARY OF THE INVENTION 
       [0015]    It is an aim of the present invention to improve the known devices. 
         [0016]    More specifically, it is an aim of the present invention to provide a device that is easy to use. 
         [0017]    Another aim of the present invention is to provide a device that is able at the same time to be used as a brace and also as a stimulating device for electrical stimulation of the user. 
         [0018]    It is a further aim of the present invention to provide a device that allows an easy and adjustable placement of electrically active zone (such as electrodes). This placement will be possible horizontally along the brace&#39;s stripe and vertically perpendicularly to the stripes. 
         [0019]    A further aim of the present invention is to provide a device that allows an easy replacement of electrically active zones. 
         [0020]    Another aim is to include on the brace electrically active zones or sensors that are able to carry out measurements on the body, for example: EMG (electromyography), brace position, angle, number of flexions, etc. 
         [0021]    Another aim is to make the brace more compliant for a practitioner. It will be possible to record values measured by the sensors in order to evaluate the accurate use of the brace and the state of recovery of the body part that is being treated via appropriate analysing and evaluation means. 
         [0022]    In the present application, it is understood that the notion of brace covers in a general manner all types of braces, that is for example soft braces, rigid braces, splints etc and other similar devices that can be worn by a user/patient. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    The present invention will be best understood from the following description of several illustrative embodiments and from the drawings in which 
           [0024]      FIG. 1  illustrates a first embodiment of the device according to the invention; 
           [0025]      FIG. 1A  is an illustrative implantation of the embodiment of  FIG. 1 ; 
           [0026]      FIG. 2  illustrates a variant of the first embodiment; 
           [0027]      FIG. 2   b  illustrates a variant of the first embodiment with a conductive Velcro®; 
           [0028]      FIG. 3  illustrates a detail of an element of  FIG. 2 ; 
           [0029]      FIG. 4  illustrates a second embodiment of the invention; 
           [0030]      FIG. 4A  illustrates a detail of  FIG. 4 ; 
           [0031]      FIGS. 5 and 6  illustrate a cut view of the second embodiment; 
           [0032]      FIGS. 7 ,  7 A and  7 B illustrate a variant of the second embodiment; 
           [0033]      FIG. 7C  illustrates a variant of the second embodiment 
           [0034]      FIG. 8 ,  8 A,  9  and  10  illustrates another variant of the second embodiment. 
           [0035]      FIG. 11  illustrates the electric connection between the conductive electrode, the stripe, the brace and the stimulator; 
           [0036]      FIG. 12  illustrates a way of connecting the stripe to the brace. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0037]    In  FIG. 1 , a first illustrative embodiment of the device according to the invention is represented. This figure is a cut view of the embodiment represented at  FIG. 1A . 
         [0038]    In the first embodiment, the brace  1  is for example made of metal (other material being possible of course), and is placed on a patient&#39;s leg or arm or any body part that has to be treated (such as leg, arm, wrist, elbow, shoulder etc.). The example of  FIGS. 1 and 1A  illustrates as an example the application to the leg P of a person. Between the two ends of the brace  1 , there is a strap  2  which is for example used to properly apply the brace on the limb of the user (see for example  FIG. 1A ). 
         [0039]    The strap has two ends  3 ,  4 , at least one of said ends being detachable from the brace to allow adjustment to the user. In  FIG. 1 , both ends  3 ,  4  are detachable and are attached to the brace through an opening (slot) in the brace and through Velcro™ means V or equivalent means. 
         [0040]    In the embodiment illustrated in  FIG. 1 , the electrically active zone  5  can be embroidered on a support  6  for example made of fabric. Of course, the embroidering is only one example for realizing the electrically active zone  5 . Other ways can be imagined and used in an equivalent manner. For example the active zone  5  could be made of an electrically active patch (carbon sheet or any other conductive material) attached to the support  6  or to the strap  2 . 
         [0041]    Preferably, the support  6  is made of a fabric strap that is folded and attached to form a “loop patch” that is then mounted on the strap  2 . In this way, the support  6  can be displaced at will along the strap  2  to be at the desired position. Of course, it is also possible to use a fixed support or to provide the electrically active zone directly on the strap  2 . 
         [0042]    In addition, a conductive wire  7  is connected to the electrically active zone  5 , said wire  7  running along the brace to a an electrical contact  8  for connection to a stimulator  9 . Preferably, the connection of the wire to the active zone  5  is made by a detachable connector. Similarly, the connection of the stimulator  9  to the electrical contact  8  can de a detachable connection. In a variant applicable to all the embodiments described herein, the stimulator  9  may be connected and attached directly to the brace  1  itself. 
         [0043]      FIGS. 2 ,  2   b  and  3  illustrate a variant wherein the wire  7  of  FIG. 1  is replaced by equivalent means. In this variant, the support  6 ′ is also made for example of a strap of fabric with a first embroidered electrically active zone  5 ′. In addition, the support  6 ′ comprises a second embroidered electrically active zone  10  on the other side of the strap  6 ′ with respect to the first zone  5 ′. Both zones  5 ′ and  10  are electrically connected to each other by a conductive wire  11 . The wire  11  may be a wire with an outer non-conductive isolation, and the contact between the wire  11  and the zones  5 ′ and  10  is preferably made when embroidering the zones  5 ′ and  10  by direct stitching through the isolation of the wire  11 . 
         [0044]    In addition, in this variant, the strap  2 ′ (corresponding to the strap  2  of  FIG. 1 ) is modified in the following manner. It also comprises an embroidered electrically active zone  12  which is connected to a wire  13  preferably having a non-conductive isolation used for connection to a stimulator (not represented in  FIGS. 2 and 3 ). As with the support  6 ′, the electrical connection between wire  13  and zone  12  is for example made by direct stitching through the isolation of the wire  13  when embroidering the zone  12 . An example of this embroidering technique is disclosed in WO 2006/060934. Of course, the electrically active zones may be realized by other techniques than embroidering or other equivalent means. 
         [0045]    As illustrated in  FIG. 2 , the support  6 ′ is placed on the strap  2 ′ with the zone  10  of the support  6 ′ contacting the zone  12  of the strap  2 ′ to allow the stimulation signal to be transferred from the stimulator to the electrically active zone  5 ′. 
         [0046]    Of course, it is also possible to combine the use of a wire (as described in reference to  FIG. 1 ) and the variant of  FIGS. 2 and 3  (use of several electrically active zones) according to circumstances. 
         [0047]    In  FIG. 2   b , the strap  2 ″ comprises a zone with a conductive attachment means  12 ′, for example a conductive Velcro® connected to a leadwire  13 . The support  6 ″ comprises the electrode  5 ′ which is connected via the leadwire  11  to a conductive zone  10 ′ made for example of a conductive Velcro® cooperating with the attachment means  12 ′ for allowing the electrical stimulation to reach the electrically active zone  5 ′. 
         [0048]    Also, it is possible in a variant to embroider the electrically active zones directly on the strap rather than on a support (such as support  6  or  6 ′). 
         [0049]    In further variants, it is possible to place the electrically active zones on other parts of the brace (for example on cushions of the brace). In this case, the electrically active zone can be directly embroidered on said cushions or on a support that is placed over said cushions. As described hereabove, the electrical connection to the stimulator may be realized by wires or by embroidered contacts. 
         [0050]    Preferably, in addition, one uses a gel electrode  14  (see  FIG. 1 ), for example having one or several conductive gel layers, or conductive paste that is placed between the electrically active zones and the surface of the skin of the user. 
         [0051]    As mentioned above, the mentioned embroidered electrically active zones can be made of other equivalent means that are non-embroidered, such as electrically conductive elements, sheets of appropriate materials suitable for the intended use etc. In this case, these electrically conductive element can be attached to the brace (or part of the brace such as a strap etc) by any appropriate means, such a glueing or other equivalent means. 
         [0052]    A second embodiment of the invention is described with reference to  FIGS. 4 to 7B . In this embodiment, the electrically active zone is more integrated in the brace. More specifically, the brace  20  (see  FIG. 4 ) comprises an opening  21  (or window) where an electrically active zone has to be placed. In addition, the brace  20  comprises a strap  22  in the region of the opening  21  the use of which will be explained later. 
         [0053]    In  FIG. 4A , a detail of the opening  21  is illustrated. In this opening  21 , one shows the skin  23  of the user, a first non conductive layer  24  and a conductive layer  25  (for example an embroidered conductive layer or a soft conductive layer, for example a carbon layer, or another equivalent conductive layer). 
         [0054]    In  FIGS. 5 and 6  (illustrating respectively an open configuration and a closed configuration), the layers  24 ,  25  described with reference to  FIG. 4A  are illustrated in a cut view for a better understanding. Over the skin  23  of the user, there is the first non-conductive layer  24 , then the conductive layer  25 , with a neighbouring layer  26  and a top layer  27 . All these layers  24 - 27  are in fact part of the brace  20 . 
         [0055]    In addition, in  FIGS. 5 and 6 , one has represented the electrically active zone  28  (for example a gel electrode having one or several conductive gel layers, or conductive paste) that is placed over the opening for the electrical treatment of the user/wearer. This electrically active zone  28  comprises a flat part  29  and a local thickness  30 , the use of which will be explained later. 
         [0056]    A represented in  FIGS. 5 and 6 , the electrically active zone  28  is placed over the opening  21  and in contact with the conductive parts  25  which are on both sides of the opening  21 . The strap (when being attached) passes over the electrode  28  and presses said electrically active zone  28  into the opening thereby ensuring the contact with the parts  25 . In addition, because of the local thickness  30 , the electrically active zone  28  is deformed and pushed into the opening  21  in order to contact the skin  23  of the wearer, as is illustrated in  FIG. 6 . In such a position, it is then possible to carry out a treatment (for example an electrical stimulation) of the wearer. 
         [0057]      FIGS. 7 ,  7 A and  7 B illustrate a variant of the second embodiment. In this variant, the electrically active zone  31  is of a different type. The electrically active zone  31  is made of a non conductive backing  32  carrying a conductive layer  33 . In addition, it comprises a strip of conductive gel  34  which is used to contact the skin of the wearer. The system according to this variant is represented in a mounted state in  FIG. 7 . In this variant, the brace is similar to the one of  FIGS. 4-6  and reference is made to its description hereabove. 
         [0058]    In  FIG. 7C , a local thickness  30 ′ is used to properly apply the electrically active zone  5  against the skin of a user P is located on the strap  2  rather that on the electrically active zone (as is  FIGS. 5-7B ) the rest of the device being similar to the one represented in  FIGS. 5-6 . 
         [0059]    In order to connect the conductive parts  25  (and the electrodes  28  or  31 ) to the stimulator (not shown in these figures) one may use wires or other equivalent means as described in relation to  FIGS. 1-3  and the electrically active zone can be made of different equivalent ways, as taught in the present application. 
         [0060]    Another variant is illustrated in  FIGS. 8 ,  8 A,  9  and  10 . In this second variant, the brace  40  also comprises an opening  41  and a strap  42  (as in the preceding variant). However, in this variant, the strap comprises an electrically active zone  43 , for example an embroidered electrically active zone. As illustrated in  FIGS. 9 and 10  (respectively an open and a closed configuration), the system further preferably comprises an additional electrically active zone  44  (for example a gel electrode having one or several conductive gel layers, or conductive paste) that is placed in the opening  41 . The strap is closed over said electrically active zone  44  which then is in electrical contact with the zone  43  thus allowing an electrical treatment of the wearer.  FIG. 9  shows the situation when the strap  42  is still open and  FIG. 10  when the strap  42  is closed thus pressing the electrically active zone  44  between the zone  43  and the skin  45 . 
         [0061]    Preferably, the opening  21  or  41  is larger than the size of the electrode to allow a better positioning of the electrically active zone. 
         [0062]    For connection of the zone  43  to a stimulator (not shown, but similar to the one illustrated in  FIG. 1 , reference  9 ), it is possible to use wires and other equivalent means, as for example described in relation to the preceding figures and embodiments of the present application. 
         [0063]    In  FIG. 11 , one has represented a way to connect a stimulator to the brace. In this example, the brace  1  comprises a snap connector  50  cooperating with corresponding snap connector  51  itself connected to a stimulator  52 . This facilitates the connection of the stimulator  52  and avoid errors in connection of wires. Of course, the connector could be made of any other kind of connector known on the market and the connection are liked to wire (for example wire  56 ) for the use of the device. For example, the wire  56  can be used for the electrical supply of the electrically active zone carried on the strap  2 . Typically, the embodiment of  FIG. 1  could be used with the snap connector system illustrated in  FIG. 11  and the example of  FIG. 11  can be transposed to the embodiment of  FIG. 1 . 
         [0064]      FIG. 12  illustrates a variant to electrically connect the brace to the electrically active zones, this variant being applicable to all embodiments described in the present application. In this illustrative example, one uses a non-conductive (or isolated) buckle  53  with a conductive part  54  (for example a loop wire). In addition, there is a wire  55  that is connected to said conductive part. The strap  2  comprises a conductive embroidery or Velcro® V and passes over the conductive part  54  thus allowing an electrical contact. The strap  2  may be formed as in  FIG. 2  or  2   b  with a wire (for example wire  13 ) for electrical contact with a support  6 ,  6 ′ and finally the electrically active zone used for stimulation. 
         [0065]    Of course other equivalents may be envisaged as well and the invention is not limited to the illustrative and exemplary embodiments and variants described herein. For example, the electrically active zones can be embroidered as described above, or other equivalent techniques may be used to form such active zones. They can be made of a conductive carbon layer, or another type of conductive layer that is attached to the brace, for example by snap connectors, Velcro®, glueing or other equivalent means. 
         [0066]    In all the embodiments described above, the stimulator ( 9  or  52 ) may be connected to the electrodes or electrically active zones/pads through cables. When using cables, it may be advantageous to use connector (such as a snap connector) having one part attached to the brace (for example as illustrated in  FIG. 11 ). This snap connector system may by asymmetrical to allow only one single connecting position and avoid errors. 
         [0067]    In a further variant, it may be envisaged to connect directly the stimulator to an appropriate connection part attached to the brace. The stimulator will then be supported by the brace itself. 
         [0068]    In order to measure values and evaluate said values, the use of the brace/device and also the state of recovery of the wearer, appropriate means are used, such as specific programs and measurements. 
         [0069]    Also, although illustrative examples have been described as using conductive embroidered zones as electrically active zones, this should not be construed as limiting on the elements used as electrically active zones. They can be made of other means, for example conductive sheets, and other suitable equivalent means attached to the brace itself or to padding of the brace. 
         [0070]    As can be understood from the above description, the present invention may be used as a stimulating device for the user with specific electrical stimulation being applied to the wearer of the brace through the electrically active zones, or also the same device made be used for electrical measurements on the user. Typically, some electrically active zones may be used for stimulation while other electrically active zones may be used for measurement. 
         [0071]    In an embodiment, the electrically active zones may be used alternatively for stimulation or measurement. 
         [0072]    In another embodiment, certain electrically active zones are used for measurements while a stimulation is carried out with other electrically active zones. 
         [0073]    As one will readily understand, the measurement can be made via said electrically active zones, or it can be made via dedicated sensors, for example position sensors, motion sensors, displacement sensors and other equivalent sensors present on the brace or attached to the brace. 
         [0074]    In such embodiments, the measured values can be brought back to the stimulator in a feedback loop to adapt the stimulation parameters used. In another variant, the measured values can be stored somewhere, for example in the stimulator or on a computer for subsequent analysis. The transmission of data can of course be made via wires or wireless. The subsequent analysis can be for example tracking of the effective use of the brace or other device being worn, correlation of the use and stimulation with improvements for the wearer, short, medium or long term analysis of the effectiveness of the brace or device being worn coupled with the electrical stimulation.