Abstract:
A neck restraint system for surgical candidates and recovering patients has at least one or more rigid or semi-rigid members including a fabric cover for supporting a plurality of cushioning or padding elements. The cushions elements are preferably conformable fabric bags partially filled with either memory elastic foam and/or foam beads to provide conformability. The fabric cover provides for exterior cosmetic customization and secure juxtaposition of replaceable and/or exchangeable cushioning elements. The cushioning elements are disposed over and around the edges portions of the rigid or semi-rigid restraint members that would otherwise rub, chafe or abrade the skin even if padded. Periodic changes of the type of cushioning elements prevent and alleviate such skin irritation and provide greater patient comfort.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application claims the benefit of priority to the US Provisional Patent Application of the same title, which was filed on Sep. 11, 2012, having application No. 61/699,386, which is incorporated herein by reference. 
     The application as filed contains one or more claims having an effective filing date after Mar. 16, 2013. 
    
    
     BACKGROUND OF INVENTION 
     The present invention relates to cervical restraint collars, and more particularly, collar padding components, systems and assemblies. 
     The prior art discloses numerous padding designs for neck braces that are for comfort or decorative, as well as a neck brace cover. 
     As shown in  FIG. 1 , a representative prior art neck brace  50  has a front member  10  that supports the patients neck at the chin in an upright position by coupling to the chest, whereas the attached rear member  20  support the rear of the neck below and between the ears via a coupling to the patients back. 
     In some prior art designs, the front member  10  has at least two components, that is an upper components  11  the is placed under the chin, wrapping around both sides of the jaw that can be flexed slightly relative to a connected a Y-shaped lower component  12  having padded plate, that is at the bottom of the Y, which that is biased to lean against the patient&#39;s chest about the sternum. Further, the coupling  15  between the upper and lower components is adjustable to accommodate the size and anatomy variations of each patient. The upward extending arms of the Y-shape generally arc around the upper chest just below the connection to the neck. The coupling is typically strapping or belts  15  that attaches to the rear member  20 , and extends into slot on the side or edge of the front or other member,  10 . When the strap s  15  are or deploy adjacent hook and loop fasteners on their faces they are readily attached to themselves after tensioning, thus securing the front  10  and rear  20  supports together around the patient&#39;s upper chest and neck. 
     The back member  20  may similarly have an upper  21  and lower component  22  that allows some flexure, as well as adjustability. The upper components  12  and  22  are wing shaped with a saddle like central depression for supporting the neck/chin or neck/back of the head junctions. The lower components is generally Y-shaped, with the lower end biased to lean against the back just between the shoulder blades, and the upper arms of the Y-shape arcing around the base of the necks to joint with the opposing arms of the Y-shaped front member. The arms of the front and rear brace members are connected after fitting to the patient via a plurality of straps  15  having an adjustable length to accommodate patient size and anatomy variations. The upper component of the back portion is attached to the lower portion at the crux of the legs of the having a bow tie shape to wrap around the rear of the neck. Upper and lower portions  11 / 12  or  21 / 22  connect by adjustable latching slot and pot connected at the sides, with a flexible linked tab connector at the center. The tab flexes so the upper portion conform to the neck shape without stressing the neck and vertebra. 
     The braces  10  and  20  also deploy internal slots or holes  30  for surgical access, as well as the placement of post surgical drains and the like. The holes or slots not only provide a space open for tubes and drains after surgery but also allow fresh air to flow into the brace and allow the heat from the body around the neck to escape. 
     The cervical brace systems described above are sold with integrated padding on the inner surfaces, but the outer shell is visible. While the padding will compress to accommodate the patient&#39;s external anatomy and is intended to minimize patient discomfort, the softness will diminish from the uncompressed state. More significantly, as the patient can often be wearing these devices for many months, the integrated padding solutions in commercial devices eventually become from uncomfortable and irritate or chafe the skin such that almost any movement become painful. 
     It is therefore a first object of the present invention to provide greater patient comfort and improved skin care by eliminating the chafing that inevitable occurs with the long term use of such padding. 
     It is another object of the invention to provide an aesthetic improvement over the appearance of the neck brace. 
     It is an addition object to obtain improved patient compliance with an improved cervical neck brace or collar. 
     SUMMARY OF INVENTION 
     In the present invention, the first object is achieved by providing a kit for a neck brace comprising at least one outer cover for surrounding a relatively rigid portion of the brace member, a first and second pair of inner cushion member, each adopted for interchangeable attachment to an interior portion of the outer cover. 
     A second aspect of the invention is characterized by a neck brace cover comprising a first brace covering fabric means, an inner cushion means for attachment to the brace covering fabric means, wherein the inner cushioning means is a flexible fabric member partially filled with a conforming material. 
     Another aspect of the invention is characterized by the neck brace cover in which the conforming material is selected from the group consisting of flowable beads and foam strips. 
     A further aspect of the invention is characterized by the neck brace cover in which the conforming material is convoluted shape memory foam. 
     A further aspect of the invention is characterized by the neck brace cover in which the conforming material is convoluted shape member foam having peaks and valleys and flowable beads are disposed within the valleys of the shape memory foam. 
     Yet another aspect of the invention is characterized by the neck brace cover in which at least one inner cushioning means has 2 or more compartments, one compartment filled with flowable beads and the other compartment filled with foam strips. 
     The above and other objects, effects, features, and advantages of the present invention will become more apparent from the following description of the embodiments thereof taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A and 1B  are front elevations of prior art neck brace components. 
         FIG. 2  is a perspective view of the prior art neck brace components of  FIGS. 1A and 1B . 
         FIG. 3  is a perspective view of the neck brace components of  FIG. 1  and  FIG. 2AB  deploying the inventive cushioning system and covers. 
         FIG. 4A  is a cross-sectional elevation view of one of the neck brace and attached covers in  FIG. 3  illustrating a preferred placement of cushioning members, whereas  FIGS. 4B  and C are front and rear elevation view of the fabric cover. 
         FIG. 5  is a rear elevation view of the fabric cover of  FIGS. 4B and 4C  after attachment to a neck brace component. 
         FIG. 6A-G  are schematic cross-sectional elevation views of alternative embodiments of the cushioning members for attachment to the interior of the fabric covering shown in  FIG. 3-5 . 
         FIG. 7  illustrates in a schematic perspective view a kit comprising a fabric cover and multiple pillows for attachment thereto. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to  FIGS. 1 through 7 , wherein like reference numerals refer to like components in the various views, there is illustrated therein a new and improved cervical restraint and padding system generally denominated  100  herein. 
     In accordance with the present invention the cervical restraint system  100  deploys a front brace  10  having at least a semi-rigid brace plate for fixing the angulation of the chin with respect to the chest and precluding neck rotation and a rear brace  20  of at least a semi-rigid plate attached at opposing sides to the front brace for limiting a patients neck movement, and at least one fabric cover  110  or slip cover for covering the front or rear brace, but more preferably both the front and rear brace on the inside and outside thereof 
     At least one padding member or pillow  120  has a means  125  for attachment to the interior side of the fabric cover  110 , the padding member  120  preferably being a flexible fabric bag  114  partially filled with a conformable supporting material  140 , of which various alternative and preferred embodiments are described in further details below with respect to  FIG. 6 . 
     In alternative embodiment of the invention the padding member  120 / 130  deploys as an attachment means  125  hook and loop (Velcro™) fasteners attached to the rear of the fabric cover  100 . 
     Fabric cover  110  is preferably securely fastening to the front  10  or rear brace  20  by an attachment means  115  that includes extending over the brace and the holes therein to attach to itself. As shown in  FIGS. 4B and 4C , such a fabric cover  110  is formed of a front  111  and a rear fabric panel  112  which are sewn together at the common edges  111   a , each panel having an aperture  113  or aperture forming portion  113  for inserting a rigid brace member to be covered and/or to coincide with the holes  30  in the braces members. Hence, the brace member  10  or  20  essentially fills the pocket formed between the front and rear fabric member or panel, with such access optionally provided by at least one side slot or opening in which common edges  111   a  are not sewn together, such that this opening at the adjacent edges penetrates into the interior of the fabric cover  110 . More preferably, the fabric cover  110  has an aperture  113  forming portion that folds to connect to itself at aperture  30  in the brace members to provide such an attachment means  115 , as shown in  FIG. 5 . The edges  111   a  can be completely sewn together provided aperture  113  is large enough for inserting the front or rear brace. 
     In the embodiment of  FIG. 4  such an aperture forming portion  113  comprises a star like slit pattern  117  capable of being opened to form an aperture. At least one of the front  111  and rear panel  112 , and optionally both, have this star slit pattern  117  formed at the intended position of aperture  30  in the brace member  10  or  20 . Opening the slits to form an aperture in the cover provides triangular portions of the extra fabric  119  between each adjacent slit pairs. Hence, after insertion of a brace member  10  or  20  attachment of this extra fabric  119  from one of the front  111  and rear panel  112  to the other panel securely positions the cover  110  on the brace after insertion, yet avoids closing the brace apertures  30 . It also provides a provides a secure attachment of the cover  110  to the brace member  10  or  20  for proper placement of cushions  120  or  130 . Thus, the margin  17  of the aperture  30  in the brace  10  or  20  is covered by extra fabric  119  from the aperture  113  that was formed in the front or rear fabric panel. The extra fabric  119  at the aperture  113  in the outer fabric cover panel  111  preferably extends inward to attach to the inner panel  112 , and is preferably attached by hook and loop (Velcro™) fasteners  118 . As shown in  FIG. 4C  and  FIG. 5 , hook and loop (Velcro™) fasteners  125  are also attached to the inner panel face or mated attachment to corresponding hook or loop members  725  attached to the outside of pads  120 / 130  ( FIG. 7 ) for secure attachment to the portion of the fabric cover  110  that will face the patient when it is inserted on the brace  10  or  20 . 
     It has been discovered that the most comfortable solution for padding a neck brace is to deploy fabric bags that are only partially filled with a least one of a compressive or flowing medium, which are soft and compliant. By a partially filled fabric bag we mean a compliant fabric bag or pillow  114  that is under filled to the extent that it is not extended to the full external volume permitted by the pliable fabric, or that if it is filled to this shape, it has an unfilled volume. Further, the filling medium  140  should be compliant to reshape the filled volume in response to the user&#39;s limited movement.  FIG. 6A , shows an unfilled bag formed of 2 fabric panels, whereas  FIG. 6B  shows the same bag filled. 
     Padding member  120  or  130  is preferably a flexible fabric member partially filled with a conforming material  140 , the flexible fabric being breathable and preferably a cotton fiber fabric or a cotton fiber blend, but is optionally flannel, fleece, microfiber synthetic fabrics. In a preferred embodiments, the padding member  120  is a fabric bag  114  that is filled with flowable beads  141  and another portion  126  filled with foam strips  142 . Portion of the padding member with flowable beads  141  is positioned at the brace margins  10   a  or  20   a  where the edges thereof are capable of contacting the skin. The shape of the pads are generally, but not exclusively dictated by the shape of the rigid or semi rigid brace itself because the pads must fit in the brace components without sticking too far out under or over the rim of the brace and the pads need to be shaped in such a way that they do not interfere with the air hole. Thus, when the front brace  10  has a Y-shape the attached padding members  120  together generally form a Y-shape. 
     It has been discovered that this requirement can be met by 2 alternative constructions, as well as combination of the same. In a first construction the filler is foam beads  141  that are free flowing within the bag  114 . As the fabric bag  114  is under filled, the beads  141  can flow as well as deform when they are disposed between the brace device and the patient&#39;s body, as is illustrated in  FIG. 6D   
     Alternatively, the requirement for an under filled compliant pillow can be met by under filling the fabric bag with a convoluted shape memory foam  142 , as shown in  FIG. 6C . Such convoluted foam  142  is typically used in packing crates. As shown in  FIG. 6C , the convolutions present peaks that hold up the fabric, possibly to an outer profile that may approach the filled shape. However, as there are air gaps between the peaks, the foam can flow into these gaps, as well as compress in response to the patient&#39;s limited movement. 
     In a more preferred embodiment of the padding members  120 / 130  illustrated in  FIG. 6F , the shape memory foam strips  142  is in a lateral center pockets  127  with soft free flowing bead in a pocket above  128  and a pocket below  129  the lateral center pocket  127 . Generally, the shape memory foam  142  is compressed before insertion into the fabric bag  114  that forms the padding member  110  or  120 . 
     In a more preferred embodiment illustrated in  FIG. 6G , the padding members  120  or  130  can be filled in a single pocket with a combination of shape memory foam  142 , in the form of strips or the shape of the pocket, along with a plurality of soft free slowing beads  141 . The beads are preferably adding both before and after inserting the shape memory foam  142 . This configuration gives a foam neck support having intermediate stiffness between the harder fill of only beads ( FIG. 6D ), and the softer filler of only shape memory foam ( FIG. 6C ). These various combinations provide users with the opportunity to switch between padding members having three levels of contact force as needed to improve skin comfort. However, this characterization of stiffness is relative to the foam and bead materials actually used for the filler, as the relative firmness of the three types of filling will depend on the stiffness and compressibility of the bead forming material, the relative degree of stuffing of beads in the pocket, and the firmness and compression of the shape memory foam. 
     It should also be appreciated that another alternative embodiment is the similar combination of the shape memory foam strips  142  with soft free flowing beads  141  in one of the pockets  127  and  128  in the padding members  120 / 130  illustrated in  FIG. 6F . 
     Hence, the fabric bag  114  when partially filed conforms to shape of at least a portion of the brace members  10  and  20  and when attached to the cover  110  extends over the relatively rigid edges of the brace  10 / 20  that would otherwise be directly exposed to the patient&#39;s skin 
     It should be understood that the padding members are not limited to just the preferred embodiment s described above, as the padding can deploy in whole or part different external and internal materials, such as soft materials and fabrics, such as fleece, microfiber fabrics as an outer cover, as well as the more preferred embodiment of breathable cotton. 
     It has also been discovered that any type of pad filled with one type of material used the entire time the patient wears the brace will not continue to be as comfortable as it initially was or continue to reduce the pressure points because the weight of the head and the pressure of the rim eventually starts to be felt through any pad. The skin adjusts to the feel and texture of the pad and with pressure from the weight of the head, movement, laying down, riding in a car, or leaning head against the back of the chair these pressure points on the tissue become increasingly aggravated. 
     In accordance with another aspect of the invention, a kit  100  as shown in  FIG. 7  comprises, at least one but preferably 2 or more fabric covers  110 , a first padding member  120  and a second padding member  130 , that is exchangeable with the first member for attachment to the fabric cover. Each of the first and second padding members are partially filled with a different conformable supporting material  140 . The kit provides for the patient to select from 2 and preferably 3 sets of pads that are interchangeable to be mixed and matched to adjust for comfort and reduce pressure points that may occur over time. More preferably, such a kit  100  includes at least one set of three padding members  120 / 130  of the same shape with each member of the set having a different level of stiffness to enable the users to vary the contact force exerted by the cushioning member against the skin, when compressed by the brace  10 / 20 , as needed to improve skin comfort. 
     Hence, the invention described herein in the different embodiments results in greater patient comfort, aesthetic improvement by choosing the outer fabric cover  110  to be decorative and match other clothing, as well as improved skin care and condition due to the non chafing nature of the padding member  120 / 130 , and their ability to deform partially. These improvements in comfort and aesthetics also lead to better patient compliance in using the neck brace. 
     While the invention has been described in connection with a preferred embodiment, it is not intended to limit the scope of the invention to the particular form set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be within the spirit and scope of the invention as defined by the appended claims.