Abstract:
The invention provides a cervical spine immobilization device that is deployed in the field to contact both sides of the head as well as the jaw, neck and/or cervical collar. The device may be formed in the shape of a polyhedron with a number of cuts to form articulated links or extensible sections. The extensible sections form at least two articulated blocking sections that may be positioned on either side of the head. There may also be multiple extensible sections to form four blocking sections, two of which may be arranged on either side of the head and two that are articulated to compress against the jaw, cervical collar or neck of a patient. The extensible sections may also be easily torn to allow removal of blocking sections to improve patient access or to fit the device to the patient. The device provides a disposable restraint that provides secure immobilization and is adjustable to fit nearly any head size. The cervical spine immobilization device also provides firm restraint during transport of athletes wearing helmets.

Description:
BACKGROUND 
       [0001]    Cervical spine immobilization devices have been used for many years by emergency medical technicians. To secure a patient having a suspected spinal injury to a back board. After trauma such as motor vehicle crashes, falls and sports injuries where spinal injury is suspected, patients are secured to a spine board using webbing across the chest, stomach and knees. The neck is immobilized using a cervical collar and the head is secured to the board using a head immobilization device. The patient is then transported to and emergency department for further evaluation and care. Secure immobilization is important in preventing additional injury, which may lead to paralysis. 
         [0002]    Head immobilization devices fall into two general categories. Reusable head immobilization devices are typically formed of a vinyl coated foam blocks and may be washed following use. Recently, these reusable devices have fallen out of favor due to the effort required to clean blood and other bodily fluids from the pads and the high replacement cost. Typically, the patient is left at the hospital or air evacuated with the head immobilization device in place. Often the device is not returned. In response to these drawbacks, disposable head immobilization devices have been developed. These disposable devices are typically formed of cardboard, are substantially less expensive and do not require cleaning. However, it is believed that some degree of security and immobilization is lost. 
         [0003]    One typical reusable head immobilization device is shown in U.S. Pat. No. 6,659,104 which shows a lower pad fixed to the spine board and having hook and loop fasteners the lower pad. The &#39;104 patent also includes two lateral pads which are affixed to lower pad by the hook and loop fasteners and are retained against the head by adjustable straps. Many other similar cervical spine immobilization devices are available; the most common of these is sold by FERNO-Washington Inc. (Wilmington, Ohio, USA) under the trademark Universal Head Immobilizer. 
         [0004]    Disposable cervical spine immobilization devices are available in a number of configurations. U.S. Pat. Nos. 6,158,819 and 6,176,549 disclose a foldable cardboard head rests that form triangular shaped support members on opposite sides of the patient&#39;s head. U.S. Pat. No. 5,146,641 discloses a cervical spine immobilization device with flaccid loops that are designed to receive compressible blocks to form triangular support members. U.S. Pat. No. 6,966,321 discloses a complex head immobilization device that includes a head harness, a forehead strap, a chin strap, a crown strap and a lateral stabilization strap. U.S. Pat. Nos. 6,913,584; 6,398,747 and 7,297,127 disclose a head immobilization device that includes a pair of arms that may be folded upward by pulling on an actuating device. The actuating device is linked to the outer ends of the arms for folding the arms symmetrically and uniformly. U.S. Pat. No. 5,211,185 discloses restraint having a base portion which is adhered to the spine board and a flexible portion that encircles the head with a band of material. 
         [0005]    Typically, these cardboard restraints are secured to the board with a double faced adhesive prior to positioning the patients. Securing the restrain to the board poses a number of problems. Typically, it is desired to position the patient on the board and subsequently position the cervical spine immobilization device without lifting or moving the patient&#39;s head. Pediatric patients are often immobilized in a car safety seat, rather than removing the child from the seat. The double faced adhesive does not adhere to the material of the safety seat and other materials must be used. Patients with hyperkyphotic (head forward) posture, which is often accompanied by an upper thoracic hump, cannot be laid flat on a spine board and must be supported, typically with blankets. Cardboard restraints using double faced adhesive are typically not suitable for hyperkyphotic patients. 
         [0006]    Disposable foam restraints have also been developed to limit head and neck movement. U.S. Pat. No. 6,088,855 discloses a pediatric cervical neck support, which is not for use in emergency medical situations, having a semicircular recess cut out from a foam support. U.S. Design Pat. No. D535,920 shows a pad for head and neck restraint that is a generally horseshoe shaped pad. U.S. Pat. No. 4,528,981 teaches two foam cylinders with a flexible connection to allow the cylinders to roll in toward one another to contact the patients head. These foam restraints typically do not conform to the head and do not contact the patients head consistently. 
       SUMMARY 
       [0007]    In accordance with embodiments of the present invention, the present invention relates to an articulated cervical spine immobilization device which conforms to the head. The cervical spine immobilization device of the present invention includes a unitary construction with extensible sections to allow the cervical spine immobilization device to be stored compactly. The cervical spine immobilization device of the present invention is deployed in the field to contact both sides of the head as well as the jaw, neck and/or cervical collar. In one embodiment, the cervical spine immobilization device is formed in the shape of a polyhedron with a number of cuts to form articulated links or extensible sections. The extensible sections form at least two articulated blocking sections that may be positioned on either side of the head. In another embodiment, there are multiple extensible sections to form four blocking sections, two of which may be arranged on either side of the head and two that are articulated to compress against the jaw or cervical collar. In yet another embodiment of the invention, the extensible sections form easily torn sites to allow removal of articulated blocking sections or extensible sections to improve patient access or to fit the cervical spine immobilization device to the patient. The cervical spine immobilization device may have a generally circular or a polyhedral cross section. The extensible sections may be formed in a molding process, with a second material, or may be formed by a series of cuts across a portion of the cross-section. The cervical spine immobilization device provides a disposable restraint that provides secure immobilization and is adjustable to fit nearly any head size. The cervical spine immobilization device also provides firm restraint during transport of athletes wearing helmets. 
         [0008]    In accordance with additional embodiments of the present invention, cervical spine immobilization system is formed of a body having at least one link section dividing the body into a plurality of articulated blocking sections suitable for use in immobilizing a patients head. Generally, the cervical spine immobilization device includes three link sections and four blocking sections two blocking sections contact the cranium to limit motion and two sections contact the jaw and neck or cervical collar to further limit motion. A link section may be included between the two blocking sections that contact the cranium to improve stability and to ease application of the cervical spine immobilization device. Another aspect of the present invention includes separate articulated blocking section without a linking section that may be applied to either side of the head. The cervical spine immobilization device system without the link include two unitary bodies, each of which including two blocking sections and an articulated link therebetween. The articulated sections may be formed in a variety of ways including forming one or more cuts in the material of the blocking sections, one particularly useful link configuration is 3 substantially parallel cuts, two from the exterior of the restrain, as the system is fitted to the patient and one cut from the interior of the restraint to form what is referred to as a W-cut. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    A more complete appreciation of the invention and the many embodiments thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein: 
           [0010]      FIG. 1  illustrates a perspective view of a unitary cervical spine immobilization device of the present invention securing a patient to a spine board. 
           [0011]      FIG. 2  illustrates a perspective view of a two piece cervical spine immobilization device of the present invention securing a patient to a spine board. 
           [0012]      FIG. 3  illustrates a plan view of the unitary cervical spine immobilization device of the present invention. 
           [0013]      FIG. 4  illustrates a plan view of the two piece cervical spine immobilization device of the present invention. 
           [0014]      FIG. 5  illustrates plan view of the cervical spine immobilization device showing a generally trapezoidal cross section. 
           [0015]      FIG. 6  illustrates a perspective view of a cervical spine immobilization device in accordance with the present invention. 
           [0016]      FIG. 7  illustrates a plan view, in detail of an articulated link section usable with the cervical spine immobilization device in accordance with the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0017]    The present invention will now be described with occasional reference to the specific embodiments of the invention. This invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. 
         [0018]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for describing particular embodiments only and is not intended to be limiting of the invention. As used in the description of the invention and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. 
         [0019]    Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth as used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless otherwise indicated, the numerical properties set forth in the specification and claims are approximations that may vary depending on the desired properties sought to be obtained in embodiments of the present invention. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from error found in their respective measurements. 
         [0020]    A cervical spine immobilization device, or restraint,  10  according to the present invention is described herein with reference to the figures. As shown in  FIG. 1  and  FIG. 4 , the restrain  10  is typically used in conjunction with a spine board  50  (also known as a back board). At the scene of an injury, a patient  60  is typically fitted with a cervical collar  62 , is placed on a spine board  50  and the patient is secured by a number of straps. Once patient  10  is secured to spine board  50  the head is secured to the board using restraint  10  and straps  40 ,  42 . 
         [0021]    The restraint  10  may include a blocking section  12  for contacting and restraining the cranium of patient  60  and more specifically temporal bone, mastoid process and/or upper mandible on one side of the patient&#39;s cranium. The restraint  10  also includes blocking section  14  for contacting the patient&#39;s mandible and/or the cervical collar  62 . In the event that patient  10  cannot be fitted with a cervical collar  62 , the blocking section  14  may contact the patient&#39;s mandible and neck. Blocking sections  12 ,  14  are connected to one another by an articulated link  32 . Articulated link  32  may be formed in a variety of ways such as a flexible sheet or by one or more cuts formed in the body of the restraint  10 . 
         [0022]    The restraint  10  may include a blocking section  20 , opposite blocking section  12  for contacting and restraining the cranium of patient  10 . The restraint  10  also includes blocking section  18 , opposite blocking section  14 , for contacting the patient&#39;s mandible and/or the cervical collar  62 . Blocking sections  18 ,  20  are connected to one another by an articulated link  34 . 
         [0023]    Restraint  10  may also include a central blocking section  22  connected to blocking section  12  and blocking section  20  by articulated links  30 ,  36 . The articulated links  30 ,  32 ,  34 ,  36  may be formed in a variety of ways such as a flexible sheet adhered between the adjacent blocking sections or one or more cuts formed in the body of the restraint  10 .  FIG. 1  and  FIG. 4  shows W-cuts  30 ′ and  32 ′ formed by a single cut formed from the interior face  10   a  of restraint  10  and  2  substantially parallel cuts made from exterior surface  10   d  of restraint  10 .  FIG. 4  shows W-cuts  34 ′ and 36′. 
         [0024]    Restraint  10  may also include a head pad  38  to raise the head of patient  60 . The head pad  38  may increase patient comfort, and also serves to keep the spine of patient  60  inline during transport and may improve the ability to maintain an open airway. In some cases, a patient with forward head posture (anterior head translation) may require a large head pad  38  to compensate for the curvature of the spine. Often emergency medical personnel will use folded blankets or towels to provide additional padding for the base of the head, in which case, the restraint  10  may be place on the additional padding (not shown). 
         [0025]    Another cervical spine immobilization device, or restraint,  110  according to the present invention is described herein with reference to the figures. As shown in  FIG. 2  and  FIG. 5 , the restrain  110  is a used with spine board  150 . The patient  160  is fitted with cervical collar  162 , placed on spine board  50  and secured by a number of straps. The head is then secured to the board  150  using restraints  110  and straps  140 ,  142 . Strap  142  may include forehead pad  144  to increase patient comfort, strap  140  may also include a pad, similar to forehead pad  144 . 
         [0026]    The restraint  110  may include a blocking section  112  for contacting and restraining the cranium of patient  160 . The restraint  110  may also include blocking section  114  for contacting the patient&#39;s mandible and/or the cervical collar  162 . In the event that patient  160  cannot be fitted with cervical collar  162 , the blocking section  114  may contact the patient&#39;s mandible and neck. Blocking sections  112 ,  114  are connected to one another by an articulated link  132 . Articulated link  132  may be formed in a variety of ways such as a flexible sheet or one or more cuts formed in the body of the restraint  110 . A second restraint, substantially similar to or a mirror image of restraint  110  is placed opposite restraint  110 . Blocking section  118  is shown in  FIG. 2  in contact with the mandible of patient  160  and cervical collar  162 . The restraint  110  may include a blocking section (not shown), opposite blocking section  112  and an articulated link (not shown). 
         [0027]    The articulated link  132  may be formed in a variety of ways such as a flexible sheet adhered between the adjacent blocking sections  112 ,  114  or one or more cuts formed in the body of the restraint  110 .  FIG. 2  and  FIG. 5  show W-cut  130 ′ formed by a single cut formed from the interior face  110   a  of restraint  110  and two substantially parallel cuts made from exterior surface  110   d  of restraint  110 . Restraint  110  may also include a head pad  138  to raise the head of patient  160 . 
         [0028]    Another cervical spine immobilization device, or restraint,  10  according to the present invention is shown in  FIG. 3 . Similar to that shown in  FIG. 4 , the restrain  10  may include a blocking section  12  for contacting and restraining the cranium of patient  60 , blocking section  14  for contacting the patient&#39;s mandible and/or a cervical collar. Blocking sections  12 ,  14  are connected to one another by an articulated link  32 . The restraint  10  may include a blocking section  20 , opposite blocking section  12  for contacting and restraining the cranium of patient  10  and blocking section  18 , opposite blocking section  14 , for contacting the patient&#39;s mandible and/or the cervical collar. Blocking sections  18 ,  20  are connected to one another by an articulated link  34 . In contrast to the restraint of  FIG. 4 , the restraint of  FIG. 3  does not include a central blocking section  22  but a central articulated link  30 , which may be formed of a W-cut, as described with reference to  FIG. 1  and  FIG. 6 , or may include additional cuts to allow for additional expansion and movement from link  30 . 
         [0029]    A cervical spine immobilization device or restraint  10 , according to the present invention is shown in  FIG. 6 . As can be seen, the restrain  10  has a patient contact surface  10 A, an upper surface  10 B, a generally trapezoidal cross-section  10 C an outer surface  10 D, a base  10 E and a longitudinal axis  10 L. The restraint  10  includes blocking sections  12 ,  14 ,  18 ,  20  and  22  separated by articulated links  30 ,  32 ,  34 ,  36 . During use, restraint  10  may be placed so that surface  10 A is in contact with the head and neck of patient  10  and surface  10 E is in contact with spine board  150 . The head and neck are then secured to the spine board  150  by straps  40 ,  42 . Straps  40 ,  42  may be formed of medical tape, a dual adhesive tape (shown in U.S. Pat. No. 5,360,393, entitled “Dual Adhesive Strap for Head Immobilization” and showing California Medical Products, Inc. as Assignee, herein incorporated by reference in its entirety) or a pre-formed tape having a pad  44  (as shown in  FIG. 1 ) to contact the forehead, chin and/or cervical collar. Straps  40 ,  42  draw restraint  10  in toward the head of patient  60  to improve stability and ‘lock’ the head in position. 
         [0030]    An articulated link  30 , according to the present invention is shown in  FIG. 7 . The link  30  may be of any suitable configuration or material. One suitable construction for articulated link  30  is referred to as a W-cut in which a cut  30 A is made from one side of restrain  10  while two cuts  30 B,  30 C are made from the opposite side of the restrain. Generally, a more flexible restraint  10  is formed when cut  30 A is made from the patient contact surface  10 A, and cuts  30 B,  30 C are made from side  10 D so that cut  30 A is between cuts  30 B and  30 C. The flexibility of articulated link  30  is increased when cut  10 A is made so that it ends before contacting surface  10 D and the end of cut  30 A is roughly the same distance from surface  10 D at upper surface  10 B and lower surface  10 E, resulting in an extension cut  30 A′ from cut  30 A that is not visible from the upper surface  10 B. Improved flexibility and consistent manufacture may also be obtained when cuts  30 A,  30 B and  30 C are parallel to one another and/or perpendicular to the longitudinal axis  10 L of the restraint. 
       EXAMPLES 
       [0031]    The present invention will be better understood by reference to the following examples which are offered by way of illustration not limitation. 
         [0032]    The material of the restraint may be any flexible and conformable material that is sufficiently rugged to survive use in emergency medical situations. One suitable material is polymer foam. Foamed polyurethane is one especially suitable material. Table 1, below shows three suitable materials available from William T. Burnett Company of Jessup, Md., USA. While polyether polyurethane foam and polyester polyurethane foams are listed below, any suitable material may be used. Materials with widespread allergies, such as latex, should be avoided. 
         [0000]    
       
         
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                   
                   
                   
                   
                 Compression Force 
               
               
                   
                   
                 Tensile Strength 
                 Elongation 
                 25% Deflection 
               
               
                   
                 Density 
                 (KPa) 
                 (%) 
                 (kN/m2) 
               
             
          
           
               
                   
                 (Kg/M 3 ) 
                 Minimum 
                 Average 
                 Minimum 
                 Average 
                 Minimum 
                 Average 
               
               
                   
               
             
          
           
               
                 SEN Polyether 
                 28.8 ± 10% 
                 83 
                 172 
                 140 
                 250 
                 133 N/m 2   
                 178 N/m 2   
               
               
                 Polyurethane Foam 
                   
                   
                   
                   
                   
                   
                   
               
               
                 S82N Polyester 
                 32.0 ± 10% 
                 110 
                 138 
                 90 
                 116 
                 3.8 kN/m 2   
                 5.2 kN/m 2   
               
               
                 Polyurethane Foam 
                   
                   
                   
                   
                   
                   
                   
               
               
                 S82C Polyester 
                 25.6 ± 10% 
                 117 
                 172 
                 80 
                 120 
                 4.1 kN/m 2   
                 5.9 kN/m 2   
               
               
                 Polyurethane Foam 
               
               
                   
               
             
          
         
       
     
         [0033]    As set fourth in Table 2, a number of samples were made. Each sample included two primary blocking sections ( 12 ,  20  in  FIG. 4 ) for contacting and restraining the cranium of patient  60  (listed as PBS, in Table 2), two secondary blocking sections ( 14 ,  18  in  FIG. 4 ) for contacting the patient&#39;s mandible and/or the cervical collar  62  (listed as SBS, in Table 2) and a central blocking section ( 22  in  FIG. 4 ) for contacting the top of the patients head (listed as CBS, in Table 2). The material and geometry of Samples 1-6 are set forth in TABLE 2. 
         [0000]    
       
         
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 2 
               
               
                   
               
               
                 Sam- 
                   
                   
                   
                 Base  
                 Top  
                   
                   
                   
               
               
                 ple 
                 Material 
                 Height 
                 Length 
                 Width 
                 Width 
                 PBS 
                 SBS 
                 CBS 
               
               
                 (—) 
                 (—) 
                 (cm) 
                 (cm) 
                 (cm) 
                 (cm) 
                 (cm) 
                 (cm) 
                 (cm) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 1 
                 S82N 
                 12.5 
                 52 
                 12 
                 6.5 
                 16 
                 6.0 
                 7.5 
               
               
                 2 
                 S82N 
                 14 
                 56 
                 9 
                 5.5 
                 14 
                 8.0 
                 10.0 
               
               
                 3 
                 S82C 
                 15 
                 55 
                 11.5 
                 8 
                 16 
                 6.5 
                 10.0 
               
               
                 4 
                 S82C 
                 14 
                 55 
                 12.5 
                 8.5 
                 16 
                 6.5 
                 10.0 
               
               
                 5 
                 SEN 
                 15.4 
                 55 
                 12 
                 7.5 
                 16 
                 6.5 
                 10.0 
               
               
                 6 
                 SEN 
                 14 
                 55 
                 12 
                 8.5 
                 16 
                 6 
                 10.5 
               
               
                   
               
             
          
         
       
     
         [0034]    Preliminary measurements of stability were taken by placing an EMT-Paramedic on a spine board in a cervical collar (Laerdal Stifneck® Select extrication collar, available from Laerdal Medical Corporation Wappingers Falls, N.Y., USA) with straps at the nipple, navel and knee (standard EMS protocol). The cervical spine immobilization device of the present invention was applied as shown in  FIG. 1 , the Laerdal Headbed II head restraint (Laerdal Medical Corporation Wappingers Falls, N.Y., USA) and the Multi-Grip Head Immobilizer (available from Itek Manufacturing Winnsboro, Tex., USA) as directed by the manufacturers. Data was also collected when the patient was secured to the board using a strip of tape across the forehead and a second strip of tape across the chin and cervical collar. The movement was measured by nose movement in one direction when the patient was asked to turn his head. The patient was also asked to give a subjective rating of stability on a scale of 1 to 10. The data is shown in TABLE 3, below. 
         [0000]    
       
         
               
               
               
               
             
               
               
               
               
             
           
               
                 TABLE 3 
               
               
                   
               
               
                   
                   
                   
                 Stability 
               
               
                   
                   
                 Distance 
                 (Subjective 1-10) 
               
               
                   
                 Restraint  
                 (cm) 
                 (—) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 1 
                 1.0 
                 8 
               
               
                   
                 2 
                 1.0 
                 9 
               
               
                   
                 3 
                 1.1 
                 7 
               
               
                   
                 4 
                 1.0 
                 7 
               
               
                   
                 5 
                 1.1 
                 5 
               
               
                   
                 6 
                 1.1 
                 6 
               
               
                   
                 Headbed II  
                 1.9 
                 6 
               
               
                   
                 Multi-Grip 
                 2.5 
                 4 
               
               
                   
                 Tape Only 
                 1.9 
                 3 
               
               
                   
               
             
          
         
       
     
         [0035]    The present invention should not be considered limited to the specific examples described herein, but rather should be understood to cover all aspects of the invention. Various modifications, equivalent processes, as well as numerous structures and devices to which the present invention may be applicable will be readily apparent to those of skill in the art. Those skilled in the art will understand that various changes may be made without departing from the scope of the invention, which is not to be considered limited to what is described in the specification.