Abstract:
A neck collar with a first shaped condition adequate for application to the patient&#39;s neck, mold and conform to the patient&#39;s neck configuration, retain and recall that configuration following removal and reapplication to the patient. A second shaped condition for storage. The collar is achieved by a unique piece of conformable material that is sufficiently resilient to maintain the given shape. The main body is designed to provide support and recall the anatomic shape of a particular patient&#39;s cervical spine.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of Utility Model Application number MI2013U000109, filed Mar. 26, 2013, with the Chamber of Commerce, Industry, Craft and Agriculture of Milan, IT, by the present inventor, Flavio Limontini, CEO of FLAMOR, s.r.l., with headquarters located at NOVARA (NO), VIA BIANDRATE 80, 28060 SAN PIETRO, ITALY, which application is incorporated herein by reference. 
     FIELD OF THE INVENTION AND BACKGROUND 
     The invention relates to a stabilizing neck collar for fixation of the cervical vertebrae and more particularly to a conformable cervical collar with an ergonomic design that patterns itself to a patient&#39;s neck. 
     Adjustable neck braces in the prior art include inflatable head and neck supports. Other devices for the same purpose are provided with panels that are connected by means of positioning grooves and have adjustment knobs. Other cervical devices include one or more opposing arms for folding between a flat and an upright position for engagement by a locking device. 
     Still other cervical collar devices have a shell with front and back members and means to adjustably join the members using a plurality of elongated slits. 
     Review of these disclosures indicates that what is needed is a conformable cervical collar that is easy to use. The requirement is for a neck brace that can be applied to a patient with minimal displacement of the neck and reduced disarticulation of the cervical vertebrae. 
     Moreover, there is a need for a brace which can initially be molded to a patient&#39;s neck. And then, having sufficient resilience following removal of the brace for rehabilitation requirements, sleeping or bathing, the resilient brace retains its prior form for reapplication to restore cervical support to the same patient without further adjustments. 
     DESCRIPTION OF THE PRIOR ART 
     The following prior art discloses the various aspects in the design and use of adjustable cervical collars. 
     The patent for a SPLINT AND METHOD OF APPLYING SAME, U.S. Pat. No. 3,943,923, granted to Samuel Scheinberg, Mar. 16, 1976, discloses a splint comprising an elongated rectangular flat strip of malleable metal that is rollable and foldable into a compact package for storage or shipment. 
     U.S. Pat. No. 4,676,233, for MANUALLY FORMED SPLINTS HAVING SHEET METAL STRUCTURE, was issued to Samuel Scheinberg, Jun. 30, 1987, provides a splint of thin malleable sheet metal, preferably dead soft aluminum, wherein a stiffening flange or rib that extends longitudinally and centrally along the material to support the body member on which the splint is used. 
     Applicant&#39;s cites U.S. Pat. No. 5,060,661, to Thomas L. Howard, dated Oct. 19, 1991, titled INFLATABLE NECK AND HEAD SUPPORT, which features an inflatable closed chamber for encompassing the neck and supporting the head of the wearer. 
     A patent for a SURGICAL COLLAR AND LINER THEREFOR, Pat. No. Re. 35,290, was granted to Sue Druskoczi, on Jul. 2, 1996, which discloses a liner formed of a blank of soft pliable material conformed to the interior surface of a surgical collar. 
     U.S. Pat. No. 8,449,485, issued to Michael D. Modglin, May 28, 2013, discloses a CERVICAL COLLAR WITH CABLE REEL ADJUSTMENT SYSTEM. 
     SUMMARY OF THE INVENTION 
     The object of the invention is a cervical collar and, in particular, a rigid cervical collar, meant to be used in EMS operations to prevent any unintended movement of the neck, such as bending, extension or rotation. Collars of this type are useful to avoid any potential damage to the cervical vertebrae which could involve permanent lesions or paralysis, and possibly even the death of the patient as a consequence of the damage to the spinal cord. 
     A cervical collar as disclosed here is designed for EMS operations. The device generally includes a body of flexible plastic material, for example polyethylene, coated with expanded closed foam, such as for example EVA or similar materials. The body of the collar includes panels that are duly shaped to offer neck support. While lower collar portions are supported by the shoulders and breastbone, the chin, jaw and head are propped up by upper collar edges. 
     This collar presents an initial flat condition that includes closure structures on the extremities, such as for example Velcro™ strips or the like. When fitting the device on the patient, the collar is duly applied behind the nape, thereafter bent in order to wrap completely around the patient&#39;s neck and fastened using the closures provided. After removal from the patient&#39;s neck, the collar can be restored to its original shape and can be stored for a next use. 
     One of the major problems of prior art cervical collars pertains to their bulk. In fact, when prior art collars are in an original flat shape, a total length can exceed 60 cm, (23.6 inches). Since such collars are often included in the standard equipment of an EMS backpack, for example during military operations in the field or during EMS actions performed by rescue teams in disaster area, reductions in length, width and bulk are desirable. 
     Another problem with prior art cervical collars relates to their complexity in application and use. For example, certain cervical collar models on the market lack a movable chin support that would make it adaptable to the patient&#39;s weight, size, configurations and proportions. Once the collar has been positioned, the chin support is moved to an advantageous position and its movement is obstructed by lack of sufficient means to maintain the desired jaw and chin position. It is therefore evident that the application of such prior art collars is overly complex, slow and potentially dangerous, giving primary consideration to the fact that such operations are often performed in unfavorable conditions where the time factor may be critical to saving the patient. 
     The device for immobilization of fractured limbs shown in U.S. Pat. No. 4,676,233, an “immobilization splint”, is made by a strip of shapeable material which could supply the necessary stiffness once duly folded in order to form fitting reinforcing ribs. This patent also describes developing a neck collar by duly shaping the malleable material. However, it is impossible to adapt this product to the shape of the neck and chin of the patient to obtain a correct and effective immobilization. The several folded areas, stiffening posts or flanges of the &#39;233 patent, which the patent requires to form the ribs for rigidity along the circumference of the neck, render the device ineffective as well as slow, complex and cumbersome to apply. 
     Thus, a primary object of the present invention is to provide an improved neck collar which is easy to apply and adjust to contours of a patient&#39;s neck. 
     Another object of the present invention is delivery of a neck collar comprising a single piece. 
     Yet another object of the present invention is to afford a neck collar which is light-weight, less bulky and easy to transport. 
     A still further objective of the present invention is the provision of a supple neck collar that molds to a patient&#39;s neck and chin having sufficient resilience to maintain its conforming shape after removal for later reapplication to the same patient. 
     Another object is formation of the collar main body using a core sheet of aluminum or its alloys surrounded by an outer coating of an expandable material, for example a polyurethane closed cell foam. 
     An added objective is to provide a neck collar opening in the throat area to allow access for a tracheotomy although the collar has already been applied to the patient. 
     Still a further goal is formation of a second opening in the body portion of the collar to allow ventilation at the nape of the neck. 
     One more object is the formation of a chin adapter with upstanding pegs which can rotate toward and away from the neck for chin support and comfort. 
     These and other objectives are achieved by the present invention as disclosed and claimed herein. Further characteristics and advantages of the invention are described below and defined in the claims. 
     The neck collar of the invention includes at least a first shape or condition suitable for application to the neck of a patient to prevent movement of the cervical vertebrae. The collar is advantageously realized with a unique piece made by a shapeable material that retains a given molded shape. And the main body is designed to present on the front side at least a partial support for the patient&#39;s chin. In a second shaped condition, the neck collar is transformed by rolling up the main body of the collar or, in the alternative, folding the main body one or more times to a minimal size that facilitates shipment and storage. 
     The designation “shapeable material” means here and subsequently, a material which can be manually misshaped, which is able to keep the determined shape, and which can be later transformed manually, to its original shape. 
     A collar according to the invention can easily be unfolded to a condition ready for use. The collar design enhances simplicity in application to a patient&#39;s neck. Thus, the neck collar according to the invention can easily be unfolded and shaped in a condition ready for use. The predetermined shape gives the collar a particular easiness in applying the collar to the patient&#39;s neck. The neck collar is just as easy to store due to the adaptability for folding the material in the most appropriate shape, rolled or folded, to occupy the smallest space. 
     The material for the main body includes for example an internal foil of aluminum or its alloys and an external coating is fabricated for example with a closed cell foam. The aluminum alloy foil facilitates folding as well as maintenance of the conforming shape while the outside coating of foam, further than being a protection coating, provides comfort for the patient. 
     According to another advantageous aspect of the invention, the section for chin support includes several small wings adjusting the collar to the shape of the face and neck of the patient. Therefore, adapting the collar to a patient is quick and easy. 
     In any case, to guarantee safety of the collar after its application, a means for repositionable closing is provided such as, for example, a system of bands retained together by opposing hooks and loops. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further characteristics and advantages of the present invention will result more evident from the following description, realized as an example, with reference to the attached drawings, wherein: 
       Drawing  FIG. 1  is an elevation view showing the neck collar in an open condition according to its preferred shape of the invention; 
       Drawing  FIG. 2  is an elevation view of the neck collar of Drawing  FIG. 1  shown in formation for use in application to the neck of a patient; and 
       Drawing  FIGS. 3 and 4  show schematic views of the shapes which the neck collar of Drawing  FIG. 1  can assume in order to limit volume and allow an easier storage in limited spaces. 
         FIG. 5  is a cross-section view along line  101 - 101  of  FIG. 1 , owing the three layers of the main body of the neck collar  10 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Drawing  FIG. 1  illustrates a neck collar  10  from an external elevation view. The broken line displays the edges of an internal core comprising a smooth pliable sheet material such as, inter alia, an aluminum foil  12 , while the edging with full stroke line indicated the coating  14 , constructed of an elastic material, such as for example a polyurethane foam, an expanded elastomer, Ethylene Vinyl Acetate foam, (EVA), or similar foam thermoplastic elastomers capable of functioning as an energy absorbing or padding material. The foil core  12  and the coating  14  are congruent and make a unique single planar piece which constitutes the main body of the neck collar  10  forming a functionally shaped support panel element. The core  12  can have for example a thickness of approx. 0.5 mm, (0.01968 in), but it can also be realized with thicknesses between 0.3 mm and 0.8 mm, (0.01181 in. to 0.03149 in.); lower ranges of thickness fail to provide a requisite collar stiffness, while higher thicknesses increase difficulty in shaping the collar. Aluminum behaves elastically under loading conditions with the ability to resume both shape and size, a preferred characteristic when flexible strength is required. The foil thickness is critical to preserve the core&#39;s energy absorption when deformed elastically wherein the cervical collar is conformed around a patient&#39;s neck by a mild hand pressure without the need for special tools or any other intervention, and to return it when unloaded in a resilient recall of the formed shape. Resilience is measured by the modulus of resilience, which is the strain energy per unit volume required to stress the material from zero stress to the yield stress. The ability to withstand such stress without fracturing is particularly desirable in medical devices, namely in this case cervical collars. 
     A laminate layer of padding forms a coating  14 , which is essentially co-extensive with the foil core  12 . Since thickness of the laminate coating  14  affects bulk of the collar, the coating is generally set so that the collar can have a total thickness included between 4 mm and 8 mm, (0.1574 in. to 0.3149 in.), for example a thickness of approx. 5 mm, (0.1968 in.). In any case it is better to establish a noticeable thickness on the edges and on the internal side, so the parts which are directly in contact with the patient are thicker, while the coating thickness on the external surface is reduced. 
     The main body of the neck collar  10  is shaped as a single planar member that is defined to form different functional support parts or plates adapted to patient structures contacted by the collar  10 ; in particular a plate  20  for the support of the chin which is flanked by two plates  30  for supporting the lower jaw, a part or plate  40  for anchoring the collar  10  against the breastbone and a part  50  for backing at the nape. 
     Between plates  20  and  40  of the collar  10  there is an opening  60  in order to allow to the EMS staff to practice any tracheotomy even when the collar has already been applied to the patient. A second opening  70  is realized in the part  50  of the body of the collar  10  in order to favor the nape&#39;s ventilation. 
     The collar  10  is moreover equipped with a repositionable closing device, such as a device with a system matching opposite bands of loops and hooks of Velcro® or similar devices. The closing device presented here includes in this case a plate  80  equipped with hooks which is fixed, for example by gluing it, to the external side of the body of the collar  10 , to the extremity which is positioned corresponding to one of the parts  30  supporting the lower jaw. At the opposite side there is opposed a band  90  equipped with loops and fixed to the internal side of the body of the collar  10  by means of rivets  91  or similar fixing devices; the band comes outside the body of the collar  10  through a slot  59  and has a length which is duly chosen to adapt the collar  10  to the several sizes for which it is intended. 
     Drawing  FIG. 2  illustrates the neck collar  10  of Drawing  FIG. 1  in an open, planar condition, i.e. the one assumed when it is applied to the patient&#39;s neck. It is notable that the section  20  comprises a chin adapter for supporting the chin and includes several repositioning upright wings or pegs  25  allowing quick and easy adaptation of the collar to the shape of the patient&#39;s jaw and chin. The wings  25 , represented in  FIG. 2  with full stroke line in their own original position can be therefore moved forward or back and shaped by a simple bend or folding in order to give them the configuration represented for example with the broken line. 
     A neck collar  10  according to the invention can also be shaped in a suitable condition to be shipped or stored in a small space, for example by shaping the main body of the collar  10  in a roll (Drawing  FIG. 3 ) or in a folded and flat condition (Drawing  FIG. 3 ). 
     In summary, the particular construction characteristic of a collar  10  according to the invention makes it easy to be folded, rolled up or anyway allows to give it reduced and compact shape and dimensions, adequate for placing it inside a rescue backpack. Once applied to the neck of the patient, the collar  10  becomes rigid so that it can immobilize it steadily. A neck collar  10  according to the invention is additionally quite light, around 100 g, (3.5274 oz.), and lends itself therefore to be adopted in a transportable EMS rescue kit without having any significant impact on their total weight. 
     Referring to  FIG. 5 , a cross-section view taken on line  101 - 101  of  FIG. 1 , there is shown the smooth pliable aluminum foil sheet  12  encased within the energy absorbing padding of a thermoplastic foam material  14 . 
     The core can also be formed of an aluminum alloy having a proof resilience, that is, a range of maximum energy that can be absorbed within the elastic limit, without creating a permanent distortion. The core modulus of resilience is computed by the formula, 
               U   r     =       σ   y   2       2   ⁢           ⁢   E             
where U r  is the modulus of resilience, σy is the yield strength, and E is Young&#39;s modulus. Of course, the core disclosed here is preferably constructed of an aluminum alloy which is within the proof resilience range so that the collar is not permanently deformed when manually molded on a patient&#39;s neck.
 
     Several modifications can be made by an expert in this field without departing from the spirit of the invention. For example, the closing device can also be different from the one which is now represented by loops and hooks. Similarly, the device can also include more than one plate of hooks  80  and even more than one strip of loops  90 .