Abstract:
A protective device for protecting the face and/or head of an individual receiving medical treatment in a face upward position includes a face portion having an exterior surface, an interior surface, and an aperture extending from the exterior surface to the interior surface, and includes a pair of opposed flexible side portions extending outwardly from the face portion. The face portion is configured to be positioned about the face of an individual with at least a portion of the individual&#39;s face exposed by the aperture, and the side portions are configured to be wrapped around and completely surround the head of the individual whereby the individual&#39;s head is supported on at least one of the side portions when the individual is receiving medical treatment in a face upward position.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     The present application is a continuation-in-part of U.S. nonprovisional application Ser. No. 14/078,004, filed Nov. 12, 2013, for HEAD AND FACIAL PROTECTIVE DEVICE, and claims priority of U.S. provisional application Ser. No. 62/152,539, filed Apr. 24, 2015, which are hereby incorporated herein by reference in their entireties. 
    
    
     BACKGROUND AND FIELD OF THE INVENTION 
     The present invention is directed to a protective device and, more particularly, to a method and apparatus for protecting the head and/or face of a patient lying in the supine position. 
     Protecting a patient&#39;s face during surgery is an important concern. Unintentional pressure on the ocular structures can cause severe damage and even blindness. Uneven pressure on the face can lead to decreased blood flow, potentially resulting in nerve damage. Compression injuries to the forehead, nose, ears, cheeks, and mouth can also occur. Once a patient undergoing a surgical procedure is fully anesthetized under a general anesthetic, the patient is no longer able to move in response to an uncomfortable or painful stimulus. Therefore, constant vigilance by the anesthesia provider is necessary to protect the vital facial structures. 
     SUMMARY OF THE INVENTION 
     The present invention provides a device and method for protecting the face and/or head of an individual receiving medical treatment in a face up, or supine, position. 
     According to an aspect of the present invention, a protective device for protecting the face and/or head of an individual receiving medical treatment in a face upward or supine position comprises a face portion having an exterior surface, an interior surface, and an aperture extending from the exterior surface to the interior surface, and includes a pair of opposed flexible side portions extending outwardly from the face portion. The face portion is configured to be positioned about the face of an individual with at least a portion of the individual&#39;s face exposed by the aperture, with the side portions configured to be wrapped around and completely surround the head of the individual whereby the individual&#39;s head is supported on at least one of the side portions when the individual is receiving medical treatment in a face upward position. 
     In particular embodiments the face portion comprises a top layer and a separate base layer, where the side portions and base layer may comprise a unitary member formed of the same material. Both the top and base layers may be constructed of foam, and in particular embodiments the top layer may be constructed of a foam that is firmer or stiffer than the foam of the base layer. Still further, for example, the top layer may be constructed to be thicker than the base layer, such as with the top layer being at least approximately twice as thick as the base layer. The top layer and base layer may be adhesively affixed together. 
     The side portions each include an end, with the ends configured to be engaged together, such as in abutting orientation, when the side portions are wrapped about the head of an individual. In a particular embodiment the side portions are of substantially similar length with respect to each other such that they extend equally from the face portion. Still further, the face portion may comprise a pair of apertures, with one of the apertures configured to expose an individual&#39;s eyes and the other aperture configured to expose the individual&#39;s nose and mouth. 
     According to another aspect of the present invention, a method of protecting the face and/or head of an individual receiving medical treatment in a face upward position includes providing a protective device comprising a face portion having an exterior surface, an interior surface, and an aperture extending from the exterior surface to the interior surface, with the protective device further comprising a pair of opposed flexible side portions extending outwardly from the face portion. The method further includes positioning the face portion about the face of an individual with at least a portion of the individual&#39;s face exposed by the aperture, and wrapping the side portions around the head of the individual to completely surround the head of the individual whereby the individual&#39;s head is supported on at least one of the side portions when the individual is receiving medical treatment in a face upward position. 
     In particular embodiments of the method, the provided protective device comprises a top layer and a separate base layer with the side portions and base layer comprising a unitary member formed of the same material. Still further, both the top and base layer may be constructed of foam with the top layer being firmer than the base layer. 
     The protective device and method of using the protective device of the present invention provide protection for a patient undergoing surgery in the supine position by allowing forces to be directed away from the sensitive areas of the face and cranial region, while providing a light weight device by way of the flexible foam construction, which promotes the prevention of injury to a patient that may result from contact with a stiffer and/or heavier protective device. The apparatus and method of the present invention also help to keep the patient&#39;s head from falling to the side, further reducing the risks of decreased blood flow and possible nerve damage. The apparatus and method, therefore, provide increased protection over conventional practices. 
     These and other objects, advantages, purposes and features of the present invention will become more apparent upon review of the following specification in conjunction with the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top perspective view of a facial and head protective device in accordance with the present invention shown in use on a patient; 
         FIG. 2  is a front-right perspective view of the protective device of  FIG. 1  shown without the patient; 
         FIG. 3  is a top plan view of the protective device of  FIG. 2 ; 
         FIG. 4  is a bottom plan view of the protective device of  FIG. 2 ; 
         FIG. 5  is a left elevation view of the protective device of  FIG. 2 ; 
         FIG. 6  is a right elevation view of the protective device of  FIG. 2 ; 
         FIG. 7  is a top end elevation view of the protective device of  FIG. 2 ; 
         FIG. 8  is a bottom end elevation view of the protective device of  FIG. 2 ; 
         FIG. 9  is an alternative embodiment of a facial and head protective device in accordance with the present invention shown in use on a patient; 
         FIG. 10  is a side-perspective view of the protective device of  FIG. 9  shown removed from the patient; 
         FIG. 11  is a front-perspective view of the protective device of  FIG. 10 ; 
         FIG. 12  is a front-perspective view of the protective device of  FIG. 10  shown in an unwrapped orientation; 
         FIG. 13  is a top plan view of the protective device of  FIG. 10 ; 
         FIG. 14  is a bottom plan view of the protective device of  FIG. 10 ; and 
         FIG. 15  is a side elevation view of the protective device of  FIG. 10 . 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention will now be described with reference to the accompanying figures, wherein the numbered elements in the following written description correspond to like-numbered elements in the figures. Referring to  FIG. 1 , a facial and head protective device  20  comprises a face portion or a central member  22  and a pair of side legs or portions  21   a ,  21   b  extending from opposite sides of central member  22 , with member  22  also including apertures  34  and  36 . Together, side portions  21   a ,  21   b  and member  22  define a recessed area or cavity  60  for receiving the head of a patient lying in a supine position when protective device  20  is placed over or about the patient&#39;s head and the distal ends of side portions  21   a ,  21   b  contact a bed, gurney, pillow, or other support surface  90  on each side of the patient&#39;s head. When so arranged apertures  34  and  36  are aligned with the patient&#39;s eyes, nose and mouth. Protective device  20  is adapted to direct forces applied thereto, such as from medical equipment or the like, to the support surface  90  to thereby protect the patient. Moreover, in the illustrated embodiment protective device  20  comprises a soft, foam-type padding that cushions the patient&#39;s face, protects pressure points, and may engage the patient&#39;s facial structures to aid in preventing shifting of protective device  20  during medical procedures, such as surgeries and the like. 
     In the illustrated embodiment the side legs  21   a ,  21   b  of protective device  20  include side members  24   a  and  24   b  and corresponding base elements or members  26   a  and  26   b , respectively. Side members  24   a  and  24   b  extend downward from generally opposite sides  32   a  and  32   b  of member  22 . Base members  26   a  and  26   b  extend outward and away from side members  24   a  and  24   b , respectively, in a plane generally parallel to central member  22 . Central member  22  has both a top surface  28  and a bottom surface  30  ( FIG. 4 ). Contact between base members  26   a  and  26   b  and support surface  90  further help in preventing shifting of protective device  20  and also allow forces applied to top surface  28  of member  22  to be directed away from the patient&#39;s face and head through side members  24   a  and  24   b  and base members  26   a  and  26   b  to support surface  90 . Additionally, central member  22 , side members  24   a  and  24   b , and base members  26   a  and  26   b  help prevent the patient&#39;s head from falling sideways, potentially decreasing the blood flow through the neck veins and arteries and leading to nerve damage. 
     Top surface  28  of member  22  is generally flat, providing a surface on which to rest surgical instruments or devices. Protective device  20  is sized whereby bottom surface  30  makes light contact with or is just above the patient&#39;s face. Member  22  may include one or more openings or apertures for various facial structures. In the illustrated embodiment, central member  22  has a generally rectangular aperture  34  for the mouth and a generally T-shaped aperture  36  for the nose and eyes, with the apertures  34 ,  36  being separated by a bridge portion  39  that is located over the individual&#39;s upper lip when protective device  20  is positioned about the patient&#39;s head. Apertures for other structures such as the patient&#39;s ears are also envisioned. Apertures  34  and  36  not only permit bottom surface  30  of central member  22  to make light contact with the patient&#39;s face, they also provide easy access to the eyes, nose, and mouth during surgery. Optionally, protective device  20  may further include a transparent eye covering or goggles  38  built in or attached to aperture  36  to offer additional protection for the patient&#39;s eyes while still allowing the anesthesia provider to easily view and monitor the patient&#39;s condition throughout the procedure. 
     With reference to  FIGS. 1 and 7 , member  22  includes upper edge  23   a  and side members  24   a ,  24   b  include upper edges  25   a ,  25   b , respectively. Similarly, with reference to  FIGS. 2 and 8 , member  22  includes a lower edge  23   b  and side members  24   a ,  24   b  include lower edges  27   a ,  27   b , respectively. Upper edges  23   a ,  25   a  and  25   b  define an upper opening  29   a  to cavity  60 , and lower edges  27   a ,  23   b  and  27   b  define a lower opening  29   b  to cavity  60 . As understood from  FIG. 1 , when in use upper opening  29   a  exposes the top of the individual&#39;s head, with lower opening  29   b  being disposed about the individual&#39;s neck. 
     On each side of protective device  20  may be one or more retaining members  40 , which may be used to attach various devices and instruments such as an anesthesia circuit  50  or the like. Securing anesthesia circuit  50  to protective device  20  helps to stabilize circuit  50  and protect against unwanted kinking in the tubing, which can lead to inaccurate readings for the anesthesia provider. Retention members  40  on both sides of protective device  20  allow the anesthesia provider to easily secure anesthesia circuit  50  to either the left or right side of the patient. In the illustrated embodiment retention members  40  are constructed as hook and loop fastening mechanisms or straps that are attached to protective device  20  at side members  24   a  and  24   b  and base members  26   a  and  26   b  through a plurality of slots  42 . However, it is envisioned that devices and instruments may be attached to protective device  20  at any number of locations and through any number of means such as, for example, tape, adhesive, or the like. One skilled in the art will recognize and appreciate the various ways devices and instruments may be attached to protective device  20 . 
     Protective device  20  is shown in  FIG. 1  with an optional protrusion or holding member  44  affixed to member  22 , with holding member  44  being positioned near the mouth aperture  34  for holding or retaining an endotracheal tube  52  inserted into the patient&#39;s mouth. Optionally, holding member  44  may be releasably attached to central member  22  such as, for example, through a hook and loop attachment so that holding member  44  may be moved by the anesthesia provider to either side of the patient&#39;s mouth and reattached. As shown, holding member  44  has a through-hole  46  that serves as the attachment mechanism for endotracheal tube  52 . Optionally, the attachment mechanism for endotracheal tube  52  may take any number of forms, such as a press-fit slot, while remaining within the spirit and scope of the present invention. 
     In operation, protective device  20  is aligned so apertures  34  and  36  are generally over the appropriate facial structures of the patient. Protective device  20  is then placed over the patient&#39;s face so base members  26   a  and  26   b  make contact with support surface  90  on each side of the patient&#39;s head. Optionally, if protective device  20  is so equipped, transparent goggles  38  may be placed over the patient&#39;s eyes and anesthesia circuit  50  and endotracheal tube  52  may be secured to either the left or right side of protective device  20  through the use of retaining members  40  and/or holding member  44 . 
     In the embodiment shown, central member  22 , side members  24   a  and  24   b , and base members  26   a  and  26   b  are each generally rectangular in shape. Side members  24   a ,  24   b  each have planar top surfaces  31   a ,  31   b  ( FIG. 3 ) and bottom surfaces  33   a ,  33   b  ( FIG. 4 ). Base members  24   a ,  24   b  each have planar top surfaces  35   a ,  35   b  ( FIG. 3 ) and bottom surfaces  37   a ,  37   b  ( FIG. 4 ). Side members  24   a ,  24   b  are connected to member  22  at angled joints  43   a  and  43   b  ( FIG. 8 ), respectively. Side members  24   a ,  24   b  are also connected to base members  26   a ,  26   b  at angled joints  45   a  and  45   b  ( FIG. 8 ), respectively. In the illustrated embodiment the internal surfaces of member  22  and side members  24   a ,  24   b  at joints  43   a ,  43   b  define obtuse angles  47   a  and  47   b  ( FIG. 8 ), respectively, and the exterior surfaces of side members  24   a ,  24   b  relative to base members  26   a ,  26   b  at joints  45   a ,  45   b  also define obtuse angles  48   a  and  48   b  ( FIG. 8 ), respectively. Also in the illustrated embodiment, the overall length  70  ( FIG. 3 ) of protective device  20  is approximately 10 inches, with member  22  having a width  72  ( FIG. 3 ) of approximately 10 inches. Base members  26   a  and  26   b  have widths  74   a  and  74   b  ( FIG. 3 ), respectively, measuring about 5 inches. Side members  24   a  and  24   b  extend downward from opposite sides of central member  22  to base members  26   a  and  26   b  defining cavity  60  having a depth  78  ( FIG. 8 ) of approximately 6 inches. It should be appreciated, however, that alternative shapes and sizes may be employed. For example, the size of central member  22  and depth  78  of cavity  60  may vary to accommodate the different physical sizes of patients&#39; heads. 
     Referring now to  FIGS. 3 and 4 , central member  22  is shown having two apertures  34  and  36 . Aperture  34  is positioned to generally align with the patient&#39;s mouth and aperture  36  is positioned to generally align with the patient&#39;s nose and eyes. Aperture  34  is essentially rectangular in shape having a height  80  of approximately 2 inches and a width  82  of approximately 4 inches. Aperture  36  is generally T-shaped with the opening for the eyes having a height  84  of about 2 inches and a width  86  of about 6.5 inches. The opening for the nose has a height  88  of approximately 4.3 inches. Such sizes are selected to accommodate variations in facial dimensions. However, it should be recognized that alternative shapes, sizes, and number of apertures may be employed. 
     In the illustrated embodiment, protective device  20  is formed by a molding process with central member  22 , side members  24   a  and  24   b , and base members  26   a  and  26   b  comprising a unitary piece of a soft, solid foam material to provide cushioned protection for the face and cranial region of the patient. Such material is light weight and easy to cut in order to gain access to the face. Additionally, such material is generally inexpensive, so protective device  20  may be disposed of after each individual use, avoiding the need to sterilize device  20  between uses. It should be appreciated, however, that protective device  20  may be formed from foam material of varying degrees of rigidity or may be constructed from any suitable light weight material, such as a plastic or polymeric material or the like, capable of providing protection for the face and cranial region of the patient. Further, as an alternative to single piece construction, protective device  20  may optionally be assembled from two or more pieces fixedly attached to each other. 
     In the illustrated embodiment, base elements  26   a  and  26   b  extend outward and away from side members  24   a  and  26   b , respectively, forming a planar surface generally parallel to central member  22 . It is envisioned, however, that base elements do not have to extend outward from side members  24   a  and  24   b , but rather may be the bottom ends of side members  24   a  and  24   b . The base elements still lie in generally in a plane parallel to central member  22  and make contact with support surface  90  to allow forces applied to top surface  28  of central member  22  to be directed to support surface  90 . 
     Referring now to the embodiment of  FIGS. 9-15 , an alternative facial and head protective device  120  is disclosed positioned on patient  15 , where patient  15  is shown in the supine position on support surface  190  with anesthesia circuit  150  provided to patient  15 . In like manner to protective device  20 , protective device  120  supports and protects the face of patient  15  during a medical procedure, as well as operates to keep the patient warm, as discussed below. Protective device  120  shares similar features and components with protective device  20 , with related features being shown in  FIGS. 9-15  with similar reference numerals, but with  100  added to the reference numerals relative to the reference numerals of device  20 . 
     Protective device  120  includes a face portion or central member  122  with a pair of side portions  121   a ,  121   b  extending in opposite directions from face portion  122 . In the illustrated embodiment, face portion  122  is constructed of a first or base layer  162  and a second or top layer  163  disposed on and connected to base layer  162 , such as by an adhesive or the like. Base layer  162  is constructed of a fire retardant polyurethane memory foam to provide a gentle cushioning material to the face of the patient. Top layer  163  is also made of a fire retardant polyurethane foam, but is stiffer or firmer than base layer  162  to provide resistance to pressure. That is, the top layer  163  is more resistant to bending or deformation. Apertures  134 ,  136  are provided through top layer  163  and base layer  162 , with aperture  136  configured for positioning about the eyes of the patient  15 , and aperture  134  configured for positioning about the mouth and nose of the patient  15 . Anesthesia circuit  150  is provided to patient  15  through aperture  134 , and may be taped to protective device  120  to aid in retention. 
     In the illustrated embodiment side portions  121   a ,  121   b  are unitarily formed with base layer  162  of face portion  122  and have approximately equal lengths to extend approximately equally from face portion  122  in opposite directions. That is, a single member or portion or layer of foam forms both the side portions  121   a ,  121   b  and the base layer  162  of face portion  122 . Side portions  121   a ,  121   b  are flexible and sized to extend from face portion  122  a sufficient distance to enable the side portions  121   a ,  121   b  to be wrapped around the head of the patient  15 . Side portions  121   a ,  121   b  include elongate ends  171   a ,  171   b , respectively, that are placed into abutting engagement with one another when positioned around the head of the patient  15  ( FIG. 10 ) to form a cavity  160  for receiving the patient&#39;s head. When so positioned, the side portions  121   a ,  121   b  can be taped together to retain the protective device  120  in position. It should be appreciated that alternatively, depending on required sizes and/or the sizes of side portions  121   a ,  121   b , that the ends  171   a ,  171   b  may overlap with one another. It should also be appreciated that the lengths of side portions  121   a ,  121   b  may be trimmed as needed for a given patient, or alternative joining techniques may be employed, such as hook and loop fastener connections or the like. 
     The wrapping of the side portions  121   a ,  121   b  about the head of the patient  15  aid in retaining the protective device  120  in position, as well as beneficially assist in keeping the patient  15  warm during a procedure. In the illustrated embodiment side portions  121   a ,  121   b  have a thickness of approximately 0.5 inches, a width of approximately 10 inches, with protective device  120  having an overall length of approximately 34 inches from end  171   a  to end  171   b  when in the position of  FIG. 13 . Also in the illustrated embodiment, top layer  163  has a thickness of approximately 1.25 inches and a length of approximately 7.75 inches. Aperture  136  is approximately 4.75 inches long and 1.25 inches wide, with aperture  134  being approximately 3.75 inches long at the lower base and approximately one inch wide about the mouth, with angled sides that are approximately two inches in length extending about the nose location. 
     The apparatuses and methods of the present invention provide protection for a patient undergoing surgery in the supine position by allowing forces to be directed away from the sensitive areas of the face and cranial region. The apparatus and method of the present invention also help to keep the patient&#39;s head from falling to the side, further reducing the risks of decreased blood flow and possible nerve damage. The apparatus and method, therefore, provide increased protection over conventional practices. 
     Changes and modifications to the specifically described embodiments may be carried out without departing from the principles of the present invention, which is intended to be limited only by the scope of the appended claims as interpreted according to the principles of patent law including the doctrine of equivalents.