Abstract:
There is provided a customizable orthotic bracing device, including an exoskeletal quasi-spinal column ( 12 ) extendable along the back of a patient and attachable to a body portion of the patient by means of a plurality of belt means ( 14, 14 ′) substantially surrounding the body portion at different points thereof, with the quasi-spinal column being comprised of a plurality of stackable and interlinkable segmental units ( 20 ), each unit consisting of a number of interlinkable sub-units ( 22, 24, 26, 28 ), characterized in that the position of the sub-units relative to one another can be adjusted in at least three degrees of freedom.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates to an orthotic device and, more particularly, to a customizable orthotic bracing device providing adjustable support and variable forces for treatment and rehabilitation of various disorders of the musculoskeletal and nervous system associated with abnormalities of posture, muscle tone and motor function.  
       BACKGROUND OF THE INVENTION  
       [0002]     The list of disorders associated with abnormalities in muscle tone, posture, and motor function is long and includes, amongst others, such problems as cerebral palsy, scoliosis, motor pareses and paralyses (of various causes), dystonia, and injuries of the spine and joints. Such problems, even when the immediate site of pathology is localized, have far-flung consequences for the entire musculoskeletal and locomotor systems. Effective treatment and rehabilitation of such problems require complex, global therapies that take into account and have an effect on the entire musculoskeletal and locomotor systems.  
         [0003]     Cerebral palsy is a chronic and persistent disorder of movement and posture caused by non-progressive pathological processes of the immature central nervous system. Injury to the brain may occur before, during or shortly after birth. The overall incidence in Western countries of cerebral palsy is between 1.5 and 2.5 per 1000 live births. An estimated 500,000 to 700,000 children and adults in the United States manifest symptoms of cerebral palsy and about 9,000 new infants develop the disorder annually. Management of the child with cerebral palsy is a complex challenge.  
         [0004]     Physiotherapy is the principal non-surgical form of treatment. Its aims are to prevent contractures and deformities and to promote functionally useful posture and movements. Cerebral palsy is typically associated with spasticity of muscle that results in the limb being held in abnormal postures. Because muscle growth depends to a certain extent on muscle stretch, if abnormal postures are maintained for extended periods, muscle growth will be impaired. Eventually, the muscle will become short and contractures will develop. Further, abnormal muscle movements tend to interfere with joint function. As a result, affected children may develop deformities, for example, of the foot or of the hip joint (which may become dysplastic or eventually completely dislocated). In general, such deformities can be minimized or prevented by splinting to maintain the joints and muscles in certain more natural positions, often designed to restrict rotational movement about a joint and providing active resistance to rotation.  
         [0005]     Several prior-art devices attempting to deal with the above-mentioned problems are extensively discussed in PCT-document WO 03/037238 A2, which is incorporated herein by reference.  
         [0006]     As distinguished from the above PCT document, the device according to the present invention is free of the encumberment of a wheel-mounted frame, while providing supportive elements that are adjustable with four degrees of freedom and adaptable to follow the spinal column of the individual patient.  
       DISCLOSURE OF THE INVENTION  
       [0007]     It is thus one of the objects of the present invention is to overcome the drawbacks and disadvantages of the prior-art devices and to provide an orthotic device that is customizable and once fitted and adjusted is easy to wear, comfortable and yet offers ample support and pressure when and where needed.  
         [0008]     According to the invention, this is achieved by providing a customizable orthotic bracing device, comprising an exoskeletal quasi-spinal column extendable along the back of a patient and attachable to a body portion of said patient by means of a plurality of belt means substantially surrounding said body portion at different points thereof, with said quasi-spinal column being comprised of a plurality of stackable and interlinkable segmental units, each unit consisting of a number of interlinkable sub-units, characterized in that the position of said sub-units relative to one another can be adjusted in at least three degrees of freedom. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]     The invention will now be described in connection with certain preferred embodiments with reference to the following illustrative figures, so that it may be more fully understood.  
         [0010]     With specific reference now to the figures in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.  
         [0011]     In the drawings:  
         [0012]      FIG. 1  is an isometric view of the device as mounted on a schematized human torso;  
         [0013]      FIG. 2  represents an isometric view of the device;  
         [0014]      FIG. 3  shows an exploded view of one of the segments of the segmented column of the device, including one of the belts;  
         [0015]      FIG. 4  is an enlarged view of the components included in square A of  FIG. 3 ;  
         [0016]      FIG. 5  illustrates a lateral view of three interlinked segments of the segmented column, showing the possibility of relative tilt of some of their components in the median plane;  
         [0017]      FIG. 6  is an isometric representation of the segments of  FIG. 5 ;  
         [0018]      FIG. 7  is a frontal view of sub-units of segments of the segmented column, showing the possibility of translational movement between the sub-units of a segmental unit;  
         [0019]      FIG. 8  is a side view of the segments of  FIG. 7 ;  
         [0020]      FIG. 9  depicts a rear view of  FIG. 7 ;  
         [0021]      FIG. 10  is an isometric view of  FIG. 7 ;  
         [0022]      FIG. 11  is a frontal view of two interlinked segments of the segmented column, showing the capability of the column to follow the outlines of a scoliotic spine.  
         [0023]      FIG. 12  is a rear view of the segments of  FIG. 11 ;  
         [0024]      FIG. 13  is an isometric view of the segments of  FIG. 11 ;  
         [0025]      FIG. 14  is a top view illustrating the capability of the segments to perform relative twists about their longitudinal axis;  
         [0026]      FIG. 15  is a bottom view of the segment group of  FIG. 14 ;  
         [0027]      FIG. 16  is an isometric view of the segment group of  FIG. 14 ;  
         [0028]      FIG. 17  illustrates the result of a spontaneous lateral torso tilt performed by the patient;  
         [0029]      FIG. 18  is an isometric view of  FIG. 17 ;  
         [0030]      FIG. 19  shows the segment of  FIG. 17  as restored to its original shape;  
         [0031]      FIG. 20  is an isometric view of  FIG. 17 ;  
         [0032]     FIGS.  21  to  23  show one of the special belt elements in three of its limit positions;  
         [0033]      FIG. 24  represents two interlinked belt elements in partial cross-section;  
         [0034]      FIG. 25  is an isometric view of the belt elements of  FIG. 24 , and  
         [0035]      FIG. 26  is an enlarged view of detail B in  FIG. 2 , showing the elastically deformable biasing means. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0036]     Referring now to the drawings, there is seen in  FIG. 1 a  split breast plate  2 ,  2 ′, contacting the front of the patient&#39;s schematized body portion, e.g., torso T. Split plate  2 ,  2 ′ is advantageously made of a canvas-type fabric and can be joined by means of a zipper  4  facilitating the donning and doffing of the entire device. To protect the closed zipper  4  against excessive lateral forces, there are provided a number of snap-in clasps  6  fixedly attached to base strips  8 ,  8 ′ of zipper  4  that must be opened before zipper  4  can be unzipped.  
         [0037]     Also seen are a pair of straps  10 ,  10 ′ slung over the patient&#39;s shoulders and fixedly attached to the uppermost member of the exoskeletal quasi-spinal column  12  ( FIG. 3 ) that is a central component of the device according to the invention and extends along the patient&#39;s back.  
         [0038]     Further seen are a number of belt elements  16  constituting pairs of belt halves  14 ,  14 ′, which between themselves, substantially surround torso T. Each belt half is comprised of a plurality of belt elements  16  hingedly articulated to one another and shown to better advantage in, and discussed in conjunction with,  FIGS. 24 and 25 .  
         [0039]     The front ends of belt halves  14 ,  14 ′ are articulated to buckles  18  having straps  19  by means of which belt halves  14 ,  14 ′ can be tightened. Certain belt elements  17  are of a special design discussed in conjunction with FIGS.  21  to  23 .  
         [0040]      FIGS. 3 and 4  represent the rear view of the device. There is seen the segmented spinal column  12  which, in this embodiment, is made up of six segmental units  20  (see  FIG. 3 ), each segmental unit consisting of four sub-units:  22 ,  24 ,  26  and  28 . The uppermost sub-unit  28  carries a cross-bar  30  to which are fixedly attached the rear ends of shoulder straps  10 ,  10 ′. The rear ends of belt halves  14 ,  14 ′ are articulated to sub-units  22  by means of hinge pins  32 ,  32 ′ ( FIG. 4 ).  
         [0041]     The entire column  12  is held together by a plurality of elastically deformable biasing means  35 , such as rubber cords or helical tension springs, threaded through holes  34  of sub-units  22  ( FIG. 2 ), anchored in uppermost sub-unit  22  and, after being imparted on initial tension, being clamped fast by lockable clamps  36  located below lowermost sub-unit  22 . These cords or springs oppose all flexing, tilting or twisting movements of column  12 , tending to restore the original, straight state of column  12 .  
         [0042]     Also seen in  FIG. 4  as part of sub-unit  22  is a central prismatic projection  38  having a slot  40  crossed by a pin  42 . Into this slot slidingly fits a wall portion  44  of sub-unit  24  having an elongated hole  46  through which, in assembly, passes pin  42  of sub-unit  22 . Sub-unit  24  has thus two degrees of freedom of movement with respect to sub-unit  22 : due to elongated hole  46 , it can move up and down, and due to the fact that the distance between its legs  48  is longer than the width of projection  38 , it can tilt laterally. Lateral tilt can be effected either by a spontaneous lateral tilt of the patient&#39;s torso, or with the aid of two screws  50 ,  50 ′ fitting threaded holes  52  in legs  48  (see also  FIG. 11 ). Further seen are also two guide rods  54  slidingly fitting holes  56  in sub-unit  26 . Movement of sub-unit  26  with respect to sub-unit  24  is effected by threading screw  58  into, or out of, threaded hole  60 . As can be seen in  FIG. 7 , threading screw  58  into threaded hole  60  causes the end of screw  58  to press against surface  62  of sub-unit  24 , thereby pushing sub-unit  26  upwards. When screw  58  is turned in the counter-clockwise sense, the above-mentioned elastic means (cords or springs)  35  will restore the displaced components to their initial position.  
         [0043]     Sub-unit  26  has two upper arms having holes  64  into which fits a rod  66  by means of which sub-unit  28  is articulated to sub-unit  26 , which is seen to consist of a T-shaped front part. The latter has been partially cut in  FIG. 3 , to show a second, advantageously integral part of sub-unit  28 , a prismatic part  68  projecting from the T-shaped front part  70 . Part  68  fits the U-shaped cutout in the upper portion of sub-unit  26  and has a transverse bore  72  into which fits rod  66 , thereby, in assembly, articulating sub-unit  28  to sub-unit  26 .  
         [0044]     Further seen is a vertical bore  74  into which fits a post  76  having a transverse hole  78  enabling rod  66  to pass. In assembly, post  76  projects from prismatic part  68  and fits a bore  80  provided in the underside of sub-unit  22  (see  FIG. 15 ), thereby facilitating stacking of the segmental units  20 .  
         [0045]     Also shown are two screws  82 ,  82 ′ (of which only one is seen) and one screw  84 . Screws  82  are instrumental in facilitating a motion of twist (see  FIG. 15 ), while screw  84  enables tilt in the median plane (see  FIGS. 5 and 6 ).  
         [0046]      FIGS. 5 and 6  illustrate the spinal column according to the invention undergoing a tilting motion in the median plane. It is seen that the segmental units undergo a tilting motion in an alternating direction when screws  84  are alternatingly withdrawn and screwed in. Clearly, such a tilting motion need not be alternating as shown, but may also be unidirectional, all according to the purpose of use or treatment.  
         [0047]     FIGS.  7  to  10  illustrate the capability of a linear, translational movement between sub-units of segmental units. It is clearly seen that when screw  58  is tightened down, a distance is created between sub-unit  24  and sub-unit  26 .  
         [0048]     FIGS.  11  to  13  shown how the spinal column of the device according to the present invention can be tilted in a lateral direction, e.g., to follow the contours of a scoliotic spine. By opening lower screw  50  and closing lower screw  50 ′ as seen in  FIG. 11 , lower sub-units  24  and  26  are tilted to the right, as is upper sub-unit  22 , while by opening upper screw  50  and closing upper screw  50 ′, sub-units  24  and  26  are tilted to the left.  
         [0049]     FIGS.  14  to  16  illustrate a twisting motion between the separate segmental units  20  ( FIG. 3 ). By opening screw  82  and turning down screw  82 ′ of one segmental unit  20 , the adjacent segmental unit  20  is imparted a twist.  
         [0050]     FIGS.  17  to  20  shown the results of a spontaneous lateral torso tilt performed by the patient, with screws  50 ,  50 ′ withdrawn. Return of the device to its original position ( FIG. 19 ) is effected by action of the patient as assisted by the elastic means  35  as seen in  FIG. 26 .  
         [0051]     The special belt elements  17  are seen in FIGS.  21  to  23 . They comprise a standard belt element  16 , a plate  86 , whereby pressure can be applied to selected points of the torso, two guide rods  88  for guiding belt element  16 , which is freely moving along them, a threaded bolt  90  fixedly mounted on belt element  16 , a cross member  92  fixedly attached to guide rods  88 , a nut  94  engaging bolt  90  and a helical compression spring  96  interposed between nut  94  and cross member  92 .  
         [0052]     This arrangement has three limit positions:  FIG. 21 , in which nut  94  is almost unscrewed and pressure on plate  86  is minimal;  FIG. 22  in which nut  94  has fully compressed spring  96 , with belt element  16  quite close to plate  86 , which can thus hardly rise, and  FIG. 23  in which belt element  16  is totally locked.  
         [0053]     In  FIG. 24 , in the partly cross-sectional view of a pair of interlinked belt elements  16  and their male and female hinge elements  98  and  100  respectively, it is seen that while the ends of hinge pin  32  are apparently a tight fit in the female hinge elements  100  to prevent its slipping out of the female hinge element, the diameter of its central section is slightly reduced to provide sufficient clearances for the belt elements  16  to move easily with respect to one another. Similar clearances are also provided between the male and female hinge elements  98  and  100 . The holes in belt elements  16  serve to reduce their weight, except with the special belt elements  17 , where the central traverse row of holes serve for the passage of guide rods  88  and the connection of threaded belt  90  (FIGS.  21  to  23 ). Not shown are paddings applied to the underside of belt elements  16 .  
         [0054]      FIG. 26 , an enlarged rendering of detail B of  FIG. 2  clearly shows the use of elastically deformable means, such as cords or springs  35  of which, for clarity, only two are shown on each side of sub-unit  22 , although there are provided enough holes  34  for six cords  35 .  
         [0055]     While the embodiment discussed in the above dealt with the device attachable to the human torso only, it is envisioned to extend its applicability also to the extremities by providing straps or belts to encompass these extremities without undue pressures thereon, for the purpose of e.g., attaching further appliances to these straps or belts.  
         [0056]     It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrated embodiments and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.