Abstract:
A shield for protecting the eye of a patient who is undergoing treatment of a facial area, such as the nose-bridge, forehead, temple, or an area immediately surrounding the eye. The shield has an outer shell of a formed semi-flexible or rigid metal foil that extends all the way to the edge of the shield, including an adhesive area of the shield that holds the shield around the eye of the patient. The foil layer is combined with one or more layers of polyester to avoid reflection of the light energy on the user or one or more layers of foam to provide for heat insulation, adhesion and patient comfort. The shield is formed at the contact portion to fit over the orbital area of the patient&#39;s eye.

Description:
[0001]    This application claims priority under 35 USC 119 to Provisional Patent Application No. 62/198,743 filed on Jul. 30, 2015 the contents of which are hereby incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to a disposable eye patch/shield. In particular, this invention relates to a disposable eye patch/shield used during surgical and/or professional facial care procedures. 
       BACKGROUND OF THE INVENTION 
       [0003]    Cosmetic surgical procedures (e.g., plastic surgery) and professional facial care procedures are becoming increasingly popular. In some cases, patients request such procedures for treatments to such facial areas as the nose-bridge, forehead, temples, and areas immediately surrounding the eyes. In performing surgical or other procedures to such areas of the faces, the procedures often require very delicate and detailed work, and therefore doctors and other professionals must have access to as much unobstructed area as possible. At the same time, the doctors or other professionals need to avoid the possibility of damaging the patient&#39;s eyes when using various surgical, medical and cosmetic items and procedures, such as lasers, intense pulse light (IPL), light emitting diodes (LED), Radio Frequency (RF), ultra-sounds, abrasion systems, chemicals, air jets, air streams, liquids, medicines, medicine applicators, surgical tools (e.g., scalpels, hemostats, needles, etc.) and other devices. Therefore, the patient&#39;s eyes are typically covered by materials such as surgical tape and gauze while a surgical or facial care procedure is being performed. However, professionals are finding an increased need for more complete access to areas around the patient&#39;s eyes, and therefore require more reliable protection methods and devices for the patient&#39;s eyes. 
         [0004]    U.S. Pat. No. 4,682,371 to Heltman discloses a protective eye patch. This eye patch has several adhesive tabs for securing an eye patch to protect the patient&#39;s eye. However, since the tabs do not seal the entire edge of the eye patch around the eye, there is a possibility that liquids or medicines may enter a patient&#39;s eye covered by this eye patch. 
         [0005]    U.S. Pat. No. 3,068,863 to Bowman discloses another type of protective eye patch. This eye patch is designed always to keep the eye closed. However, since this patch is adhered onto the patient&#39;s eyelid as well as surrounding eye tissues, this eye patch is not comfortable to wear, and this is the only option for this patch. 
         [0006]    U.S. Pat. No. 3,092,103 to Mower provides an eye patch that has a cushion material on an edge of the eye patch which allows a patient&#39;s eye to move and/or open underneath the eye patch. Because of its large size, this patch is not suitable for many surgical and facial care procedures which require a larger working area for the surgeon. 
         [0007]    U.S. Pat. No. 4,867,146 to Krupnick et al. discloses an eye patch for preventing opening of an eye and preventing corneal abrasion. This eye patch has adhesive areas around the patch and part of a center part of the eye patch. However, because of the adhesive areas in the center part, it is uncomfortable for the patient to wear, and, in fact, it is designed for use on an anesthetized patient. 
         [0008]    U.S. Pat. No. 5,180,360 to Rhame, Jr. discloses an oval shaped eye patch with a thick inner foam patch or adjustable bladder for adjusting pressure against an eyelid. It is intended to work with all energy sources that are employed in procedures that utilize medical treatment lights and even hybrid systems with light and electrical current energy units. However, this patch is quite large, being designed to attach to the outside of the eye socket, and covers some areas of the face that may need to be accessed for some surgical or facial care procedures. 
         [0009]    U.S. Pat. No. 7,584,754 to Pellegrini and Krupnick discloses a patch with a single metallic layer with one or two foam sheet members that are flat. In this patent, the foam is always exposed to a laser and the eye is in contact with the metallic layer in one version. 
         [0010]    There is therefore a need for an improved eye shield that will provide protection for the eye during any type of surgical or facial care procedure while not interfering with the particular procedure being conducted by the health care professional. The shield must also be comfortable for the patient, even though the eyelid may be open or closed. 
       SUMMARY OF THE INVENTION 
       [0011]    The eye shields of the invention are made using an outer layer of a flat or formed, semi-flexible or rigid metal foil that extends all the way to the edge of the shield, including the adhesive area of the shield that adheres to the patient. The foil layer may be combined with one or more layers of polyester foam to avoid reflection to the user or to provide for heat insulation, adhesion and patient comfort. The shield is flat or curved to the extent necessary at the contact portion to fit over the orbital area of the patient&#39;s eye. A release layer covering the adhesive is open to allow for stacking of the curved versions of the shields until ready for use. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  is a perspective view of an eye shield according to the invention; 
           [0013]      FIG. 2  is a bottom plan view of the eye shield; 
           [0014]      FIG. 3  is a side view of the eye shield of  FIGS. 1 and 2 . 
           [0015]      FIG. 4  is an enlarged view of a portion of  FIG. 3 ; 
           [0016]      FIG. 5  is a side view similar to  FIG. 3  but showing the layers of the shield separated; 
           [0017]      FIG. 6  is a sectional view of the eye shield taken on the line  6 - 6  of  FIG. 2  but showing the layers separated; 
           [0018]      FIG. 7  is a sectional view similar to  FIG. 6  but illustrating a second embodiment of the invention; 
           [0019]      FIG. 8  is a sectional view similar to  FIG. 7  but illustrating another embodiment of the invention; 
           [0020]      FIG. 9  is a perspective view of two pairs of shields ready to be stacked; and 
           [0021]      FIG. 10  is a perspective view showing the two pairs of shields of  FIG. 9  stacked. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0022]    Referring to  FIGS. 1-6  of the drawings, the basic structure of the eye shield of the invention is a semi-flexible or rigid shell  10 , preferably made from a material of some metal, such as aluminum. The shell  10  can be pure metal or metal coated with some suitable material, such as polyester or foam, but not limited to polyester or foam, on top or on both sides, as shown in the various embodiments described herein. This is so the shield can be used when shielding both a light energy beam and electrical currents. Some energy skin treatment units on the market come both with an electrical current (radio frequency (RF), and a light energy, like laser, IPL, etc. Ideally, the shell  10  will protect against units with electrical currents, such as RF, but will also protect against energies in addition to RF. The shell  10  must also withstand some energy exposure from a light beam source, such as a laser beam to be safely used as a shield. The metallic shell  10  is formed in any suitable manner to the desired shape, preferably a rounded oval, to fit within the eye socket of a patient to be treated but of a sufficient size to always cover the patient&#39;s eye. Thus, the shell  10  is shaped to fit well over the orbital rim or just inside the orbital rim of most patients. If the shield is formed from aluminum foil which is quite thin, the shell  10  will be more or less flexible and will allow for some minor adjustments after placement on the patient&#39;s orbit. If the foil is thicker, it will be less adjustable. The flexible or rigid shell  10  may also be flat or have a curvature that can vary depending upon the desired characteristics and uses for the eye shield as described hereinafter. The drawings show a moderately curved shape, but it should be understood that a flat or higher or lower curvature may be used. The higher curvature offers freedom for the eyelids and eye lashes to move when the shield is in place since a bulging cup will not touch normal eyelashes or the patient&#39;s eyelids. A curved shell is intended to be much more comfortable as there will not be any pressure on the eyelids and eyes, unless it is desired by the health care professional to keep the eyelids closed during a particular treatment by using a less curved or flat surface. 
         [0023]    In most applications and in all the embodiments shown herein, the metallic shell  10  has an outwardly and somewhat downwardly extending peripheral rim or edge  12  to provide for additional patient protection. In the first embodiment illustrated in  FIGS. 1-6 , the metallic shell  10  is bare on both sides, i.e., shell  10  has no insulating layer, except that the peripheral edge  12  has adhered to its underside surface a foam layer  14  that extends around substantially the entire edge  12 . The foam layer  14  contacts the patient&#39;s skin when the shell  10  is in place over the patient&#39;s eye. This foam layer  14  insulates the patient from heat or RF current if used by the health care professional. A suitable adhesive is applied to the underside of the foam layer  14  for the purpose of securing the eye shield to the patient. Attached to the adhesive side of the foam layer  14  is a release paper layer  16  that protects the adhesive on the foam layer until the shield is ready to be used. The layer  16  is removed when the user is ready to install the shield on a patient. The release paper layer  16  can be the same size as the edge  12  of the shield  10  or the paper layer  16  can extend beyond the edge  12 . In the drawings, release paper layer  16  is shown as extended beyond the oval shape of the edge  12  of shield  10  to make it easier to remove the release paper layer  16 . Both the foam layer  14  and release paper layer  16  are ring-shaped with their center part cut out so that the layers cover only the peripheral edge  12  of the shell  10  and do not extend inside the edge  12  of the shell  10 . This allows stacking of the shields on top of each other (as illustrated in  FIGS. 9 and 10 ). Once stacked, the shields can be placed in a box for shipping and storage until use. In the alternative, the paper layer  16  can extend across the opening of the shell  10  but simply be cross-cut in the center so it will not rip during production while still allowing the shield to be stacked. With the design of this first embodiment, the patient&#39;s eyelid would not be affected by the shield, and the patient can open and close the eyes as the rounded form of the shield gives some space over the eyelid. 
         [0024]    In a second embodiment of the invention illustrated in  FIG. 7 , the foam layer  14  is not cut out in the center but rather extends across the entire interior of the shell  10 . This foam layer  14  provides additional insulation from the energy being used during a particular procedure. As shown in  FIG. 7 , the foam layer  14  can be spaced from the interior surface of the shell  10 . The amount of spacing of foam layer  14  from the interior surface of the shell depends upon whether or not the shield is intended to press the patient&#39;s eyelid closed when the shield is in place. As shown, the foam layer  14  extends across the peripheral edge  12  and it glued to edge  12  to hold the foam layer in place. The release paper layer  16  also extends across the interior of the shell  10 , covering the foam layer  14  and preferably extending beyond the edge  12 . This embodiment is used when it is desired to press the eyelid closed when the shield is in place over the patient&#39;s eye without the foam layer  14  adhering to it, which may be more comfortable for the patient, especially when removing the shield after treatment. As an option, to provide more insulation where needed, the thickness of the foam layer  14  may be increased by the addition of a second foam layer  18 , as illustrated in  FIG. 7 . Preferably, as shown in  FIG. 7 , the second foam layer  18  does not cover the peripheral edge  12 . If desired, the entire bottom surface of the foam layer  18  may be coated with an adhesive, so that the layer  18  would adhere to the patient&#39;s eyelid. This may be desired in some instances where the health care profession wishes the patient to keep the eyelids closed during treatment. Of course, the shields of this embodiment could not be stacked in a package because the layers  14  and  16  extend across the entire opening of the bottom of the shell  10 . 
         [0025]      FIG. 8  illustrates yet another embodiment in which an additional foam layer  20  is added to the shield by gluing a foam layer  20  to the exterior of the metallic shell  10 . In addition, a first foam layer  13  extends over the entire inner surface of the shell  10  as well as the peripheral edge  12  and is glued to those surfaces. A second foam layer  15  is ring-shaped and extends only around the peripheral edge  12  and is glued to the foam layer  13 . The exposed underside of the foam layer  15  is covered by the release paper  16  which is ring-shaped and extends only around the peripheral edge  12 . The additional foam layer  20  applied to the exterior of the metallic shell  10  is used primarily where the light energy or RF system being used to treat the patient requires this additional insulation. Similar to the embodiment of  FIGS. 1-6 , the shield of this embodiment is open on the underside, so that the shields are stackable.  FIGS. 9 and 10  illustrate how the shields might be stacked. Two pairs of shields are shown with a single release paper  16  joining each pair of shields.  FIG. 10  shows the pairs stacked. 
         [0026]    In all the embodiments of the invention, the basic design of the shield allows the shield to be smaller than know shields. The metallic shell  10  is entirely of protective foil or contains a metallic substance and covers the entire eye but never touches the patient&#39;s skin. One or more of the foam layers is always beneath the metallic shell  10 . The foam layer may be ring-shaped to cover only the peripheral edge  12 , or one or more foam layers may be included to insulate the patient&#39;s skin from any excessive heat generated during the treatment by the professional. The additional foam layer(s) may be on top of the metallic shell only, or inside the shell only, or on both sides of the shell. In any case, there will always be at least a ring-shaped foam layer covered by a release paper to adhere the shield to the patient. Color coding of the shields may be used to differentiate shields of different sizes or types. In the preferred embodiments, the shields are designed to be stackable to facilitate shipping and storage until ready for use. 
         [0027]    The selection of the proper type and size of the shield by the health care professional is very important. For example, if the shield is too large for a particular patient, the patient can freely open the eyes, and if the energy source is very potent, like a Yag laser, and the patient does not listen to the instructions given by the professional to close their eyes, or the professional forgets to give the instructions, a patient&#39;s retina or cornea could be damaged. The invention provides different shield sizes and designs for differences in patient anatomy and for different treatments, and with color coding of the shields and other proper warnings, possible damage to the patient&#39;s eyes can be greatly minimized. 
         [0028]    The terms and expressions which have been used in this specification are used as terms of description and not of limitation. There is no intention in the use of such terms and expressions of excluding any equivalents, of any of the features described, or portions thereof, but it is recognized that various modifications are possible to the embodiments disclosed herein without departing from the scope of the invention. Accordingly, it is to be understood that the detailed description and the accompanying drawings are for purposes of showing the preferred and best embodiments of the invention and are not intended to limit the breadth of the present invention, but rather all modifications as would be obvious to one skilled in the art are intended to be included within the scope of the invention as defined within the following claims