Abstract:
Implementations of the present disclosure overcome the problems of the prior art by providing a brace for supporting a head of a wearer. The brace includes a head frame, a strap assembly and a cervical bar. The head frame is configured to grip the head of the wearer. The strap assembly is configured to extend along the wearers waist and back. The cervical bar has a first and second ends. The first end connects to and supports the head frame. The second end connects to and is supported by the strap assembly. Advantageously, the cervical bar has a stiffness sufficient to support the head and the head frame against head drop. The brace can do this without interfering with respiratory pathways.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of priority to U.S. Provisional Application 61/598,687, filed Feb. 14, 2012, which is incorporated by reference herein in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention pertains to a brace for providing support to the head and torso of the wearer without the use of a cervical collar, thereby improving the wearer&#39;s balance, mobility, and breathing capacity. 
       BACKGROUND 
       [0003]    Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig&#39;s disease, is a progressive neurodegenerative disease which leads to muscular weakness. This disease causes a deterioration of upper and lower motor neurons which can result in a variety of deficits including weakness, speech difficulty, swallowing difficulty, spasticity, weight loss, muscle atrophy, shortness of breath, fatigue and eventually respiratory failure. 
         [0004]    There is no known cause or cure for ALS. One of the muscle groups frequently affected with weakness and fatigue are the neck extensors. Due to this weakness, individuals lose the ability to control one&#39;s head even though they may continue to be independent with ambulation. Many people with ALS who exhibit neck extensor weakness, find it difficult to ambulate due to the flexed neck position. This flexed neck position impacts the person&#39;s ability to breathe, causes unstable balance, fatigue, pain and ultimately poor quality of life. 
         [0005]    People with neck weakness (due to ALS and other reasons) may rely on external supports for head control. Such supports include neck braces or high back wheelchairs with head supports. Multiple cervical collars are available on the market, including the Aspen collars, Head master collars, non-invasive halo, Minerva brace, SOMI brace and the MND Oxford collar. The current external supports rely upon posterior support, anterior chin support and an optional chest or back strap or plate. 
         [0006]    It would be advantageous to have a cervical spine orthosis that further improves the quality of life, balance, mobility and breathing capacity of people with ALS and other diseases. 
       SUMMARY 
       [0007]    Implementations of the present disclosure overcome the problems of the prior art by providing a brace for supporting a head of a wearer. The brace includes a head frame, a strap assembly and a cervical bar. The head frame is configured to grip the head of the wearer. The strap assembly is configured to extend along the wearer&#39;s waist and back. The cervical bar has a first and second ends. The first end connects to and supports the head frame. The second end connects to and is supported by the strap assembly. Advantageously, the cervical bar has a stiffness sufficient to support the head and the head frame against head drop. The brace can do this without interfering with respiratory pathways. 
         [0008]    The strap assembly includes at least one waist strap configured to extend at least partially around a waist of the wearer. Also included may be a posterior panel. The posterior panel may be configured to extend along a wearer&#39;s back. The posterior panel has a first end and a second end. The first end of the posterior panel is connected to the second end of the cervical bar. The second end of the posterior panel is connected to the waist strap. The posterior panel may be relatively stiff to provide additional support. 
         [0009]    The strap assembly may include shoulder straps. Each of the shoulder straps has a first end and a second end. The first end of the shoulder strap is connected to the first end of the posterior panel. The second end of the shoulder strap is connected to the waist strap. 
         [0010]    Also, the strap assembly may include an anterior panel constructed of a relatively stiff material. The anterior panel is configured to extend across a portion of the wearer&#39;s abdomen. The waist strap is connected to the anterior panel. 
         [0011]    To avoid interference with respiration, the brace may be configured to have a free area under the chin and over the chest of the wearer. The brace may be configured to be relatively free of rigid structure near a respiratory pathway of the wearer. 
         [0012]    The head frame may include a posterior portion including a stiff material having a concave shape with lateral extensions. The lateral extensions are configured to extend along lateral sides of the wearer&#39;s head. 
         [0013]    Also, the head frame may include a head strap configured to extend around a forehead of the wearer and couple to the posterior portion. 
         [0014]    A method of supporting a head of a patient using a brace. The head frame is positioned on the head of the patient. The head frame is secured to a first end of a cervical bar, where the second end of the cervical bar is secured to a posterior panel. The posterior panel is secured to the patient&#39;s torso. These steps may be executed while avoiding interference with respiration of the wearer. For example, the chin and chest area may be avoided. 
         [0015]    These and other features and advantages of the implementations of the present disclosure will become more readily apparent to those skilled in the art upon consideration of the following detailed description and accompanying drawings, which describe both the preferred and alternative implementations of the present disclosure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a rear elevation view of an example brace worn by a wearer; 
           [0017]      FIG. 2  is a front view of the example brace of  FIG. 1 ; 
           [0018]      FIG. 3  is a side view of the example brace of  FIG. 1 ; 
           [0019]      FIG. 4  is a rear plan view of the example brace of  FIG. 1 ; 
           [0020]      FIG. 5  is a front plan view of the example brace of  FIG. 1 ; 
           [0021]      FIG. 6  is a front view of an example occipital pad; 
           [0022]      FIG. 7  is a front view of an example occipital pad; 
           [0023]      FIG. 8  is a front view of an example occipital pad; 
           [0024]      FIG. 9  is a plan view of an example blank used to form a frame member; 
           [0025]      FIG. 10  is a front plan view of an example head frame; 
           [0026]      FIG. 11  is a front plan view of an example brace; 
           [0027]      FIG. 12  is a rear plan view of the example brace of  FIG. 11 ; 
           [0028]      FIG. 13  is a front elevation view of the example brace of  FIG. 11  worn by a wearer; 
           [0029]      FIG. 14  is a front elevation view of the example brace of  FIG. 11  worn by a wearer; 
           [0030]      FIG. 15  is a front plan view of an example connector; 
           [0031]      FIG. 16  is a front plan view of an example connector; and 
           [0032]      FIG. 17  is a front plan view of an example connector. 
       
    
    
     DETAILED DESCRIPTION 
       [0033]    Implementations of the present disclosure now will be described more fully hereinafter. Indeed, these implementations can be embodied in many different forms and should not be construed as limited to the implementations set forth herein; rather, these implementations are provided so that this disclosure will satisfy applicable legal requirements. As used in the specification, and in the appended claims, the singular forms “a”, “an”, “the”, include plural referents unless the context clearly dictates otherwise. The term “comprising” and variations thereof as used herein is used synonymously with the term “including” and variations thereof and are open, non-limiting terms. 
         [0034]    As shown in  FIGS. 1-5 , a brace  10  includes a head frame  12 , a cervical bar  14 , a posterior panel  20 , shoulder straps  16 , waist straps  22  and an anterior panel  24 . The head frame  12  is configured to grip the head of the wearer. The strap assembly, such as the shoulder straps  16 , waist straps  22 , posterior panel  20  and anterior panel  24 , provide a secure foundation for the head frame  12  without interfering with respiration. The cervical bar  14  is relatively stiff and connects the head frame  12  to the strapping system so as to support the wearer&#39;s head. This helps to mitigate the “head drop” in ALS patients and other patients afflicted with neck instability or insufficiency. 
         [0035]    As shown in  FIGS. 4 and 5 , the head frame  12  includes a posterior portion  26  and a head strap  28 . The posterior portion  26  includes a frame member  30 , padding  32  and a hook and loop panel  34 . The frame member  30  is formed of a relatively stiff sheet of material, such as from a 4 inch by 6 inch blank of 1/16 of an inch thick T3 aluminum sheet for smaller wearers or a 5 inch by 7 inch blank for larger wearers. 
         [0036]    An exemplary flat frame member  30  formed from such a blank is shown in  FIG. 9  and includes a central rectangular portion  36  and a pair of lateral extensions  38 . Broken lines in  FIG. 9  show where the lateral extensions  38  can be bent into the concave shape shown in  FIGS. 3 ,  4  and  5 . The central rectangular portion  36  has a slight arc curvature at its bottom edge and a relatively straight top edge. The central rectangular portion  36  is longer than it is wide and is configured to extend up along the posterior portion of the base of the wearer&#39;s head, as shown in  FIG. 1 . 
         [0037]    That lateral extensions  38  are rounded lobes of the stiff sheet material that extend slightly downwards away from the central rectangular portion  36 . As illustrated in  FIG. 10 , the lateral extensions  38  can be bent inwards to form the aforementioned concave shape, about 30 to 45 total degrees from the plane of the central rectangular portion  36 . The 45 degrees, for example, may comprise a 20 degree bend at the more medial (inner) broken lines of lateral extensions  38 . The remaining 25 degree bend is at the more lateral (outer) broken lines of the lateral extensions. Despite the initial curvature of the head frame member  30 , it may be contoured to match the wearer&#39;s anatomy for a snug comfortable fit and prevent slippage off of the occiput. 
         [0038]    Because the broken lines along which the bends are made are closer at the bottom than the top, the inside surfaces of the lateral extensions  38  are angled slightly upwards to extend along the occipital lobe and toward the center of the wearer&#39;s head. Together, the central rectangular portion  36  and lateral extensions  38  form support surfaces with a net vector directed anteriorly and superiorly to tilt the head held thereagainst by the head strap  28  into a more normal anatomical position. 
         [0039]    Wearer comfort is facilitated by use of padding  32  applied to the frame member  30 , as shown in  FIGS. 5 and 10 . Padding  32  includes a rectangular occipital pad for larger wearers, such as is shown in  FIG. 6 , or a smaller rectangular pad for smaller wearers, as shown in  FIG. 7 . Also, circular occipital pads, as shown in  FIG. 8 , are used for the lateral extensions  38 . The padding  32  may be constructed of ¼ inch VOLARA foam or ½ inch PLASTAZOTE foam. The smaller (by diameter) lateral occipital pads may be constructed of the thicker foam for more conforming support. The foam padding  32  may be attached by adhesive or fasteners to the allotted positions on the frame member  30 . 
         [0040]    The hook and loop panel  34  is a rectangular panel adhered to the upper outside surface of the central rectangular portion  36 , as shown in  FIG. 4 . The hook and loop panel can include, for example 1 inch wide by 20 inch long 50/50 Hook &amp; Loop, a 1½ inch pressure sensitive hook, and a 1 inch C-loop. This optional panel provides additional security for the loop (or hook) bearing head band or strap  28 . 
         [0041]    The head strap  28  extends in a loop around the forehead of the wearer, as shown in  FIGS. 2 and 3 . The head strap  28  thus secures the head to, and within, the upwardly extended concave receptacle formed by the frame member  30 . The head strap  28  may be formed of ⅛ inch thick by 1½ inch wide by 5 inch long neoprene strip, such as NEO-SPONGE, attached (e.g., sewn or adhered) to a 1 inch DACRON strap. 
         [0042]    The strap assembly includes the shoulder straps  16 , waist straps  22 , posterior panel  20  and anterior panel  24 . The posterior panel  20 , as shown in  FIG. 4 , is formed of a curved sheet of relatively stiff material, such as a 2 foot by 3 foot by 3/16 inch thick polypropylene sheet. The posterior panel  20  has an elongate shape and extends from the neck to the waist of the wearer. It is curved to match the kyphotic curve of the thoracic spine of the wearer. Embedded within or attached to the polypropylene sheet may be a central reinforcing strut or bar  40  for additional rigidity. The strut  40  may be constructed, for example, of a 2 inch wide, 19 inch long and ⅛ inch thickness T4 aluminum bar. The strut  40  may be inserted, attached or formed into the posterior panel  20 . 
         [0043]    The posterior panel  20  also includes shoulder flanges  42 , waist flanges  44  and a foam layer  46 , as shown in  FIG. 5 . The shoulder flanges  42  and waist flanges  44  are shaped or cut from the sheet of polypropylene. For example, the posterior panel  20  can be constructed from ⅛ inch KYDEX 430 plastic. The shoulder flanges  42  extend laterally at shoulder height from the central portion of the posterior panel  20 . They are configured to accept attachment of the shoulder straps  16 . The waist flanges  44  similarly extend laterally at waist level from the central portion. They are configured to accept attachment of the waist straps  22 . The foam layer  46  may be ¼ inch ALIPLAST foam cut to the shape of the overall posterior panel  20 , a shown in  FIG. 5 . 
         [0044]    As shown in  FIG. 4 , the shoulder straps  16  include 1 inch DACRON straps with ¼ inch VELFOAM sheets wrapped into sleeves surrounding the DACRON straps. A first end of each of the shoulder straps  16  connects by fastener to a respective one of the shoulder flanges  42 . A second end of each one of the shoulder straps ends in a 1 inch double adjustable side release buckle. The intervening length of the DACRON strap extends through a loop attached to posterior panel  20  between the two waist flanges  44 . At this point, the shoulder straps cross each other to extend back out and around the waist of the wearer to buckle to the anterior panel  24 , as shown in  FIG. 1 . 
         [0045]    The waist straps  22  connect at a first end to the waist flanges  44  via fasteners and are configured to extend around the waist and/or hips of the wearer to attach at a second end (also via fasteners) to the anterior panel  24 . The second ends each include an adjustable buckle or ring (such as a D-ring). The waist straps  22  may be constructed of 2 inch DACRON straps that extend through the ring and then double-back to attach (adjustably) to themselves with an intervening hook-and-loop connector strip. 
         [0046]    The anterior panel  24 , as shown in  FIGS. 2 and 5 , is a D-shaped panel with a flat top, arc-shaped bottom and rounded corners configured for positioning over the abdominal region of the wearer. It includes a waist strap connector  48  that is anchored at its center and its ends include mating buckle portions configured to mate with buckles on the free ends of the shoulder straps  16 . It is also constructed of a relatively stiff or rigid material. 
         [0047]    The cervical bar  14  includes a first end  50  and a second end  52  separated by a bend in the bar. The cervical bar  14  may be constructed of a ⅛ inch thick by ⅝ thick by 9½ long 2024 T4 aluminum bar. The cervical bar  14  can be adjusted to correspond to the curvature of the trunk of the wearer. For example, the height of the cervical bar  14  can be adjusted with respect to the posterior panel  20 . The first end  50  rigidly attaches via two fasteners to the rectangular portion  36  of the frame member  30 . The second end  52  extends over and attaches to the top of the reinforcing strip  40  of the posterior panel  20 . 
         [0048]    The posterior panel  20  may include a slot that receives the second end  52 . The posterior panel  20  may include an adjustable connector  60  for coupling with the second end  52 . For example, as illustrated in  FIGS. 15-17 , the connector  60  can include a pin  56  or other fastener may be used to extend into one of series of vertically spaced openings  58  defined in the second end  52  of the cervical bar  14 . The connector  60  allows the height of the head frame  12  to be adjusted relative to the posterior panel  20 .  FIG. 15  shows the cervical bar  14  in an engaged or locked position with respect to the posterior panel  20 . The cover plate  54  can be positioned over the connector  60  using a mechanical fastener.  FIG. 16  shows the connector  60  with the cover plate  54  open and the cervical bar  14  positioned/engaged within the connector  60 . The cover plate  54  can rotate/pivot at a screw/pin from an open to closed position over the connector  60 .  FIG. 17  shows the cover plate  54  in an open position and the cervical bar  14  removed from the connector  60 . As illustrated in  FIG. 17 , an example connector can include a pin  56  integral to the connector  60  for engaging the openings  58  defined in the second end of the cervical bar  14 . In a further example the pin  56  may extend from the cover plate  54  and can be selectively detached and reattached (e.g., via screws) to adjust the head frame  12  for different wearers. In another example, the pin  56  can be removably coupled to the cover plate  54  and/or connector  60 . 
         [0049]    As shown in  FIG. 3 , the bend in the cervical bar  14  is positioned to transition between the neck and the tilt for the occipital portion of the wearer&#39;s skull. 
         [0050]    The brace  10  may be donned by positioning the posterior panel  20  along the spine. The wearer places both arms through the shoulder straps  16 . The wearer secures the waist straps  22  and anterior panel  24  around their waist using the buckles. The wearer places the posterior portion  26  of the head frame  12  at the lower portion of the head. The wearer secures the head frame  12  against the base of their skull with the head strap  28 . If needed, the wearer may readjust the waist straps  22  and anterior panel  24  for improved fit. The wearer may also adjust the shoulder straps  16  to be snug with the hook-and-loop connector. 
         [0051]    Advantageously, the brace  10  positions the head in neutral or slight flexion without chin support. The brace  10  includes adjustability to adapt to different wearer physiology. Stabilization of the brace  10  posteriorly with anterior strap components extending around the waist leaves the chest, chin and throat area free for easier respiration. The anterior panel  24  may also have diaphragm assist function that facilitates breathing. The brace  10  may be worn over an undershirt to reduce chafing but under regular clothing for a more acceptable appearance. Experimental wearers of the brace  10  reported satisfaction with comfort, mobility, and ability to breathe more easily than prior art braces. In a further example, as shown in  FIGS. 11-14 , the strap assembly includes shoulder straps  16 , waist straps  22  and the posterior panel  20 , and does not include the anterior panel  24 . Shoulder flanges  42  extend laterally at shoulder height from the central portion of the posterior panel  20  and are configured to accept attachment of the shoulder straps  16 . The waist flanges  44  similarly extend laterally at waist level from the central portion and are configured to accept attachment of the waist straps  22 . 
         [0052]    As shown in  FIG. 12 , each shoulder strap  16  includes a top and bottom segment. One end of the each of the top and bottom segments connects by fastener to a shoulder flange  42 . The top and bottom segments mate/join at an adjustable buckle or ring (such as a D-ring) such that the intervening length of the joined shoulder straps  16  extends through left and right side loops attached to the left and right shoulder flanges  42 , respectively. The shoulder straps can include a 1 inch double adjustable side release buckle. The shoulder straps  16  can include VELCRO to assist in adjusting/securing the fit around the shoulders of the wearer. For example, shoulder straps  16  can include 1 inch wide by 20 inch long 50/50 Hook &amp; Loop. 
         [0053]    A first waist strap  22  connects at a first end to a waist flange  44  via fasteners and a second waist strap  22  connects at a first end to the opposite waist flange  44 . The first and second waist straps  22  are configured to extend around the hips of the wearer and mate/join at an adjustable buckle or ring (such as a D-ring). For example, the first and second waist straps  22  can be mated/joined at a 1½ inch double adjustable side release buckle. The first and second waist straps  22  can also include VELCRO to assist in adjusting/securing the fit of the waist straps  22  around the waist/hips of the wearer. For example, waist straps  22  can include 1 inch wide by 20 inch long 50/50 Hook &amp; Loop. In a further example, the brace  10  can be configured such that the first and second waist straps extend around the waist of the wearer. The waist straps  22  may be constructed of 2 inch DACRON straps that extend through the ring and then double-back to attach (adjustably) to themselves with an intervening hook-and-loop connector strip. 
         [0054]    The brace  10  may be donned by securing the posterior panel  20  to the torso of the wearer. For example, the posterior panel  20  can be positioned along the wearer&#39;s spine and a strapping system can be positioned about the torso of the wearer, including straps around the shoulders, waist and/or hips to securing the posterior panel  20  to the wearer. The strapping system can include waist straps  22  and/or shoulder straps  18 . The strapping system can also include an anterior panel  24 . The strapping system can be secured to the posterior panel  20  while donning In another example, end portions of each of the waist straps  22  and/or shoulder straps  18  are fixed to the posterior panel  20  before donning The fit of the waist straps  22  and/or shoulder straps  18  can be adjusted/secured using buckles, rings, VELCRO, etc. 
         [0055]    The head frame  12  can be positioned on the head of the wearer and head straps  28  may be secured around the wearer&#39;s head. For example, head straps  28  can be placed across the forehead and around the sides of the wearer&#39;s head. The head straps  28  can be fixedly attached to the head frame  12  prior to donning the brace, or the head straps  28  can be secured to the head frame  12  during/after donning the brace. At least a portion of the head frame  12  can be positioned along and/or in contact with the wearer&#39;s head. For example, pads  32  attached to the head frame  12  can be positioned such that they come in contact with the wearer&#39;s head during use of the brace  10 . The head frame  12  can be positioned to support a posterior and/or side portion of the wearer&#39;s head. For example, the head frame  12  can be positioned to support at least a portion of the occipital bone. The head frame  12  can be positioned such that it provides support for the weight of the wearer&#39;s head. Similarly, the posterior panel  20  can be positioned to provide support for the wearer&#39;s torso. For example, the torso/trunk of the wearer can be supported by the leverage provided between the restraint provided at the head frame  12  and the waist straps  22 . As the waist straps  22  are tightened against the body of the wearer the posterior panel  20  is brought into contact with at least the lower lumbar portion of wearer&#39;s back. The pressure/support provided against the wearer&#39;s back combined with the restrain of the wearer&#39;s head can position the wearer&#39;s torso in an upright position. By supporting the wearer&#39;s head and torso, the wearer&#39;s balance, walking ability/mobility, and/or breathing can be improved. 
         [0056]    The head frame  12  can be secured to a first end  50  of the cervical bar  14 . The second end  52  of the cervical bar  14  can be secured to the posterior panel  20 . In another example, the second end  52  of the cervical bar  14  can be incorporated into and/or constructed from a portion of the posterior panel  20 , in which case the head frame  12  can be secured to the combined posterior panel  20 /cervical bar  14 . 
         [0057]    The wearer can wear regular undergarments under the brace  10 . Moreover, regular clothing can be worn over the brace. The brace  10  can be donned without interfering with the respiration of the wearer. For example, because the brace  10  does not include a chin and/or chest strap and can be donned while avoiding the chin and chest areas of the wearer. Likewise, when being worn, the brace  10  does not restrict the ability to breath, eat, and/or speak. The brace  10  can also improve posture and visual orientation by reorienting the location and position of the wearer&#39;s head. 
         [0058]    A number of aspects of the systems, devices and methods have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, other aspects are within the scope of the following claims.