Abstract:
A mask to improve the comfort and eye health of individuals suffering from dry eye syndrome including a substantially vapor impermeable shell with a unitary structure having a substantially planar portion and two eye recesses. Each eye recess forms a generally concave dome shaped region on one side of the substantially planar portion. The shell is adapted to be worn on the face of the dry eye subject. An absorbent material can be positioned in at least one of the eye recesses; so that the absorbent material extends less than the maximum depth of the eye recesses to present the absorbent material to the face in the vicinity of the eyes of the dry eye subject without extending beyond the edge of the substantially planar portion. The invention may also include securing member to secure the shell to the subjects head.

Description:
FIELD OF THE INVENTION  
       [0001]    The invention relates to the treatment of dry eye syndrome. More particularly it relates to altering the local environment to reduce the discomfort of dry eye syndrome. 
       BACKGROUND OF THE INVENTION  
       [0002]    Masks for treatment of dry eye syndrome currently exist. Current masks for dry eye syndrome generally include a moisture impermeable and flexible enclosure and absorbent moisture reservoir, a seal, and a retaining strap or other retaining member. Currently available masks for the treatment of dry eye syndrome are designed to be used for a long period of time with the absorbent moisture reservoirs intended for repeated reuse. 
         [0003]    Generally, currently available mask products are expensive. The expense of the currently available products encourages repeated reuse of the mask as well as the absorbent moisture reservoirs by users. Because the mask and moisture reservoirs are in close contact with the skin, the mask and/or moisture reservoirs may become contaminated with bacteria or other pathogens over time. The presence of bacteria or other pathogens creates a possibility of infection in or about the skin and the eyes. It is well known that a moist, dark environment provides a favorable environment for the growth of bacteria, fungi and other pathogens. 
         [0004]    Currently available mask products may lack of sterility even at the initial use. The materials from which currently available products are made may tend to deteriorate under the conditions required for sterilization. Therefore, they are not provided in a sterile state. In addition, many of the materials are highly porous and may tend to absorb contaminants from the environment. 
         [0005]    Thus, the treatment of dry eyes would benefit from a product that reduces the risks of infection and contamination. 
       SUMMARY OF THE INVENTION  
       [0006]    One embodiment of the present invention generally includes an eye mask, absorbent pads, and an eye care solution. The present invention solves many of the above discussed problems. The eye mask is soft, flexible, resilient and able to conform readily to the user&#39;s facial structure. The eye mask is non-permeable. It provides a vapor moisture barrier to contain moisture provided by the eye care solution. In addition, the eye mask of the invention is readily sterilizable by gamma radiation without deterioration. Further, the present invention lends itself to inexpensive production thus facilitating a disposable product which can be discarded after use to minimize the risk of contamination and infection. 
         [0007]    In one embodiment, the eye mask of the present invention generally includes a shell, absorbent pads, and a retainer. 
         [0008]    The shell generally includes a planar portion, domes, and walls. 
         [0009]    In one aspect of the invention, the planar portion generally defines a brow arch, a nose relief, retainer ears, cheek arches, and dome perimeters. Brow arch is gently curved and extends generally between the retainer ears. The nose relief is centrally located on a lower edge of the shell and is formed by the juncture of the cheek arches. 
         [0010]    In one aspect of the invention, the eye mask may be formed of closed cell flexible foam. Closed cell foam has excellent water vapor barrier properties. The product may be formed from polyolefin foams such as polyethylene foam. The eye mask is soft and flexible to degree that is not seen in prior masks, allowing the mask to conform to the shape of the face and ocular adnexa to sufficiently seal the mask to the face without the need for a separate sealing member. 
         [0011]    For example, polyethylene foam sheets, such as those that can be obtained from Voltek of Lawrence, Mass. have been found to be suitable for use in the present invention. The following examples illustrate suitable qualities. 
       EXAMPLE 1  
       [0012]    foam sheet thickness 4.0 mm (Voltek of Lawrence, Mass., Code: LL1077); 
         [0013]    density 0.035 grams per cc; 
         [0014]    water vapor transmission rate 0.087 g/8 hours/100 sq inches-ASTM E96; 
         [0015]    compression set 6% original thickness-ASTM D3575; 
         [0016]    shore hardness 18 “A” scale; and 
         [0017]    25% compression load 2.5 psi-ASTM D3575. 
         [0018]    Such foam sheet material can be molded into a mask by heat and pressure. In this example the temperature of a mold was maintained at about 120° C. and the molding time was approximately 2.5 minutes. 
       EXAMPLE 2  
       [0019]    Polyethylene foam sheets (Voltek Code: LL1036): 
         [0020]    Foam sheet thickness 3.4 mm; 
         [0021]    Density 0.21 grams cm 3 ; 
         [0022]    Water vapor transition rate 0.087 g/8 hours/100 sq inches-ASTM E96; 
         [0023]    Compression set3.8% original thickness; 
         [0024]    Shore hardness 30 “A” scale; and 
         [0025]    25% compression load 8.5 psi. 
         [0026]    A mask produced from this material is less flexible than that described above in Example 1. These examples should not be considered limiting. 
         [0027]    An absorbent pad for use with the eye mask generally should demonstrate a fast rate of absorption of liquids. 
         [0028]    In one aspect of the invention, each pad may hold at least 15 grams of eye care solution under a 0.1 pound per square inch load. The absorbent pad may be lint free as much as possible. The absorbent pad, in one aspect of the invention, may be sterilizable by gamma radiation without observable damage. Finally the absorbent pad should have a low level of extractables. An example absorbent pad can be formed from pulp and super absorbent material combined with bonded non-woven materials, such as those obtained from Buckeye Technologies of Memphis, Tenn. Example material specifications are as follows: 
         [0000]    
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                   
                 Bonded 
               
               
                   
                   
                 Nonwoven 
               
               
                   
                 Pulp/SAP Blend 
                 Material 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Product Code 
                 V3921 
                 V3027 
               
               
                   
                 Basis Weight (g/m 2 ) 
                 165.00 
                 100.00 
               
               
                   
                 Density (g/cc) 
                 0.09 
                 0.05 
               
               
                   
                 SAP Cont. (%) 
                 26.00 
                 0.00 
               
               
                   
                 Pulp (%) 
                 68.00 
                 89.5 
               
               
                   
                 Binder (%) 
                 6.00 
                 10.5 
               
               
                   
                 Type of SAP 
                 Crosslinked 
                 — 
               
               
                   
                   
                 poly Acrylate 
               
               
                   
                 Residual Monomer (ppm) 
                 &lt;75 
                 — 
               
               
                   
                   
               
             
          
         
       
     
         [0029]    The absorbent pad also may include hydrotangled polyester-rayon blend fiber fabric such as that which can be obtained from PGI of Mooresville, N.C. This fabric may be used as a cover material. 
         [0030]    In addition, the absorbent pad can include a 1 mil polyethylene film such as that obtained from Tedegar Film Products of Richmond, Va. In one embodiment of the invention, the absorbent pad bonded together by a hot melt adhesive such as that which can be obtained from HB Fuller of St. Paul, Minn. 
         [0031]    Absorbent pads constructed from the above discussed materials displayed the following absorption properties: 
         [0032]    absorption capacity at 0.1 psi load 16.8 grams; 
         [0033]    rate of absorption 3.4 ml per second; and 
       These values should not be considered limiting. 
       [0034]    An exemplary eye care solution can include water, sterile water, saline solution and an aqueous solution containing electrolytes such as sodium chloride or potassium chloride. For example, a typical formulation would be: 
         [0035]    sterile water 98.9%; 
         [0036]    sodium chloride 0.5%; 
         [0037]    potassium chloride 0.2%; and 
         [0038]    glycerin 0.4%. 
         [0039]    In this example, glycerin acts as a lubricant and controls the rate of moisture evaporation from the pad. The solution may be packaged, for example, in 20 ml plastic vials. 
         [0040]    For distribution purposes, the mask, a quantity of absorbent pads, and an eye care solution vial can be packaged in a conventional plastic material such as polyester or polyethylene. The packaging may be sealed to be air tight. 
         [0041]    The eye mask can be sterilized in a cardboard case by application of gamma radiation. Approximately a 20-30 kilogray radiation dosage is expected to be required to sterilize the product. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0042]      FIG. 1  is a partially exploded perspective view of a mask in accordance with the present invention. 
           [0043]      FIG. 2  is rear plan view of the mask in accordance with the present invention. 
           [0044]      FIG. 3  is a cross sectional view of an absorbent pad in accordance with the present invention taken along section line  3 - 3  of  FIG. 2 . 
           [0045]      FIG. 4  is a perspective view of another embodiment of a mask in accordance with the present invention. 
           [0046]      FIG. 5  is a rear plan view of the embodiment of the mask depicted in  FIG. 4 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0047]    Referring to  FIG. 1 , in one embodiment, eye mask  10  of the present invention generally includes shell  12 , absorbent pads  14 , and retainer  16 . 
         [0048]    Shell  12  generally defines planar portion  18 , domes  20 , and walls  22 . 
         [0049]    Referring to  FIGS. 1 and 2 , in one aspect of the invention, planar portion  18  generally defines brow arch  24 , nose relief  26 , retainer ears  28 , cheek arches  30 , and dome perimeters  32 . Brow arch  24  is gently curved and stretches generally between retainer ears  28 . Nose relief  26  is centrally located on a lower edge of shell  12  and is formed by the juncture of cheek arches  30 . Retainer ears  28  may define apertures  34  therein for receiving retainers  16 . 
         [0050]    Referring again to  FIGS. 1 and 2 , domes  20  together with walls  22  define eye recesses  36 . Eye recesses  36  may take the shape of roughly an irregular pentagon. Eye recesses  36  have a central depth sufficient to allow absorbent pads  14  to be inserted therein while still leaving sufficient space in front of the user&#39;s eyes for an air gap between absorbent pads  14  and user&#39;s eyelids. For example, eye recesses may have a depth of approximately 1-2 cm. 
         [0051]    Referring particularly to  FIG. 3 , absorbent pads  14  generally include vapor permeable cover  38 , bonded non-woven layer  40 , pulp super absorbent polymer (SAP) blend  42 , vapor barrier  44 , and securing member  46 . Vapor permeable cover  38  may be formed of a fabric or non-fabric material which allows the passage of water vapor and related vapors. Vapor permeable cover  38  may be formed, for example, from hydrotangled polyester rayon blend fiber fabric of the type that can be obtained from PGI, Mooresville, N.C. 
         [0052]    Bonded non-woven layer  40  may be formed from an absorbent non-woven material such as that available under product code V3027 from Buckeye Technologies, Memphis, Tenn. The bonded non-woven material may have, for example, a basis weight of approximately 100 grams per square meter, a density of approximately 0.05 grams per cubic centimeter and be formed of approximately 89.5% pulp and 10.5% binder. 
         [0053]    Pulp super absorbent polymer (SAP) blend  42  may be, for example, that available under product code V3921 also from Buckeye Technologies. This material may, for example, have a basis weight of approximately 165 grams per square meter, a density of about 0.09 grams per cc, a super absorbent polymer content of approximately 26%, a pulp content of approximately 68%, and a binder content of approximately 6%. Pulp SAP blend  42  may include a super absorbent polymer of, for example, cross linked polyacrlylate having a residual monomer of less than 75 parts per million. 
         [0054]    Vapor barrier  44  may be formed from, for example, 1 mil polyethylene film such as that which can be obtained from Tredegar Film Products of Richmond, Va. Vapor permeable cover  38  may be secured to vapor barrier  44  around a common perimeter thereof by use of, for example, hot melt adhesive or another adhesive product. Vapor permeable cover  38  may also be connected to vapor barrier  44  by mechanical or other fastening approaches. 
         [0055]    Securing member  46  serves to secure vapor barrier  44  to shell  12 . Desireably, securing member  46  can be secured and removed at least several times. For example, securing member  46  may include a hook and loop system or an adhesive which can be repeatedly placed and removed. Securing member  46  may be placed into permanent contact with vapor barrier  44  or the interior of domes  20 , for example. 
         [0056]    Absorbent pads  14  may be moistened with an eye care solution. The eye care solution may be an aqueous solution containing electrolytes. Eye care solutions can include water, sterile water, saline solution and an aqueous solution containing electrolytes such as sodium chloride or potassium chloride. For example, a formulation may include sterile water 98.9%, sodium chloride 0.5%, potassium chloride 0.2%, and glycerin 0.4%. The eye care solution may also be any other aqueous solution amenable to maintaining a healthy humidity environment for the eyes. In addition, plain distilled water may be used to moisturize the absorbent pads  14 . 
         [0057]    Referring to  FIGS. 4 and 5  in another embodiment, eye mask  10  generally includes planar portion  18  and domes  20  similar to those described above. 
         [0058]    In this embodiment, eye mask  10  includes integral retainers  48 . Integral retainers  48  may form an extension  50  of planar portion  18 . 
         [0059]    Integral retainers  48  may include straps  52  and coupling members  54 . Coupling members  54  may include any sort of coupling known in the art. In this example, coupling members  54  include buttons  56  and apertures  58 . Buttons  56  may be integrally molded to straps  52  and protrude therefrom. Apertures  58  to receive buttons  56  are formed in an opposing strap  52 . Buttons  56  and apertures  58  are desirably sized so that buttons  56  may be forced through apertures  58  and retained therein, thus coupling straps  52  to each other to secure eye mask  10  about the head of the user. Other coupling members  54  may of course be used. For example, coupling members  54  may include tabs and slots or other means known to the art to couple two straps  52  together. 
         [0060]    In operation, eye mask  10  is supplied in a kit including shell  12 , absorbent pads  14 , retainer  16 , and eye care solution (not shown.) Prior to distribution, eye mask  10  is sterilized with gamma radiation or by other sterilization techniques. About a 20-30 kilogray dosage is expected to be required to sterilize the product. 
         [0061]    When a user is ready to use an eye mask  10 . The user removes shell  12  and absorbent pads  14  from packaging. The user secures absorbent pads  14  to the interior of domes  20  then applies the eye care solution to absorbent pads  14 . The user then places eye mask  10  over the eyes and face and secures it in place with retainer  16  or integral retainers  48 . 
         [0062]    Eye mask  10  with absorbent pads  14  in place, may be used during sleep or during the day for any period of time desired. 
         [0063]    Eye care solution evaporates from absorbent pads  14  to provide a humidity rich environment within eye recesses  36 , thus, reducing evaporation of tears and providing additional humidity to provide comfort and therapeutic benefits to the dry eye patient. 
         [0064]    For example, polyethylene foam sheets, such as those that can be obtained from Voltek of Lawrence, Mass. have been found to be suitable for use in the present invention. The following examples illustrate suitable qualities. 
       EXAMPLE 1  
       [0065]    foam sheet thickness 4.0 mm (Voltek of Lawrence, Mass., Code: LL1077); 
         [0066]    density 0.035 grams per cc; 
         [0067]    water vapor transmission rate 0.087 g/8 hours/100 sq inches-ASTM E96; 
         [0068]    compression set 6% original thickness-ASTM D3575; 
         [0069]    shore hardness 18 “A” scale; and 
         [0070]    25% compression load 2.5 psi-ASTM D3575. 
         [0071]    Such foam sheet material can be molded into a mask by heat and pressure. In this example the temperature of a mold was maintained at about 120° C. and the molding time was approximately 2.5 minutes. 
       EXAMPLE 2  
       [0072]    Polyethylene foam sheets (Voltek Code: LL1036): 
         [0073]    Foam sheet thickness 3.4 mm; 
         [0074]    Density 0.21 grams cm 3 ; 
         [0075]    Water vapor transition rate 0.087 g/8 hours/100 sq inches-ASTM E96; 
         [0076]    Compression set 3.8% original thickness; 
         [0077]    Shore hardness 30 “A” scale; and 
         [0078]    25% compression load 8.5 psi. 
         [0079]    A mask produced from this material is less flexible than that described above in Example 1. 
         [0080]    An absorbent pad for use with the eye mask generally should demonstrate a fast rate of absorption of liquids. 
         [0081]    In one aspect of the invention, the pad may hold at least 15 grams of eye care solution under a 0.1 pound per square inch load. The absorbent pad may be lint free as much as possible. The absorbent pad, in one aspect of the invention, may be sterilizable by gamma radiation without observable damage. Finally, the absorbent pad should have a low level of extractables. An example absorbent pad can be formed from pulp and super absorbent material combined with bonded non-woven materials, such as those obtained from Buckeye Technologies of Memphis, Tenn. Example material specifications are as follows: 
         [0000]    
       
         
               
               
               
             
               
               
               
               
             
           
               
                   
                   
               
               
                   
                   
                 Bonded 
               
               
                   
                   
                 Nonwoven 
               
               
                   
                 Pulp/SAP Blend 
                 Material 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Product Code 
                 V3921 
                 V3027 
               
               
                   
                 Basis Weight (g/m 2 ) 
                 165.00 
                 100.00 
               
               
                   
                 Density (g/cc) 
                 0.09 
                 0.05 
               
               
                   
                 SAP Cont. (%) 
                 26.00 
                 0.00 
               
               
                   
                 Pulp (%) 
                 68.00 
                 89.5 
               
               
                   
                 Binder (%) 
                 6.00 
                 10.5 
               
               
                   
                 Type of SAP 
                 Crosslinked 
                 — 
               
               
                   
                   
                 poly Acrylate 
               
               
                   
                 Residual Monomer (ppm) 
                 &lt;75 
                 — 
               
               
                   
                   
               
             
          
         
       
     
         [0082]    The absorbent pad also may include hydrotangled polyester-rayon blend fiber fabric such as that which can be obtained from PGI of Mooresville, N.C. This fabric may be used as a cover material. 
         [0083]    In addition, the absorbent pad can include a 1 mil polyethylene film such as that obtained from Tedegar Film Products of Richmond, Va. In one embodiment of the invention, the absorbent pad bonded together by a hot melt adhesive such as that which can be obtained from HB Fuller of St. Paul, Minn. 
         [0084]    Absorbent pads constructed from the above discussed materials displayed the following absorption properties: 
         [0085]    absorption capacity at 0.1 psi load 16.8 grams; 
         [0086]    rate of absorption 3.4 ml per second; and 
       These values should not be considered limiting. 
       [0087]    An exemplary eye care solution can be an aqueous solution containing electrolytes. For example, a typical formulation would be: 
         [0088]    sterile water 98.9%; 
         [0089]    sodium chloride 0.5%; 
         [0090]    potassium chloride 0.2%; and 
         [0091]    glycerin 0.4%. 
         [0092]    In this example, glycerin acts as a lubricant and controls the rate of moisture evaporation from the pad. The solution may be packaged in 20 ml plastic vials. 
         [0093]    For distribution purposes, the mask, a quantity of absorbent pads, and an eye care solution vial can be packaged in a conventional plastic material such as polyester or polyethylene. The packaging may be sealed to be air tight. 
         [0094]    The eye mask can be sterilized in a cardboard case by application of gamma radiation. Approximately a 20-30 kilogray radiation dosage is expected to be required to sterilize the product. 
       EXAMPLE  
       [0095]    A total of 22 subjects reporting a mild to moderate dry eye condition were impaneled to evaluate an embodiment of the invention over 4 weeks of nightly use. A total of 21 subjects completed the study. One subject discontinued study participation for reasons unrelated to use of the invention. 
         [0096]    Following the 4-week use period, subjects completed a computerized questionnaire regarding the invention&#39;s performance and attributes. Subjects choosing a neutral response (“neither agree nor disagree” or “not sure”) were removed from the questionnaire summary. The majority of the test population reporting an opinion indicated the following: the embodiment was easy to use, fit on the face, was comfortable on the face, improved the dry eye problem and had a favorable appearance; the eye pads provided enough humidification during use; they liked the quality and were satisfied with the embodiment. The majority of subjects reporting a preference indicated they would purchase the embodiment if it was available. 
       Panel Selection 
       [0097]    A total of 22 healthy female subjects, ranging in age from 18 to 61 years, were selected for the study. Seven subjects (approximately 32%) wore contact lenses and 15 subjects (approximately 68%) were non-contact lens wearers. 
       Test Method 
       [0098]    On the first day of the study, each subject completed a baseline questionnaire evaluating dry eye symptoms. Qualified subjects were assigned sequential subject numbers in the order of their qualification and were issued an identically numbered test kit. Subjects were given a copy of the sponsor&#39;s use directions and panelist instructions and were directed to use the test material every night at home for 4 weeks. Other than the assigned test material, the panelists were to introduce no new cosmetics during the study. Subjects were permitted to use their usual over-the-counter moisturizing eye drops as needed during the day. 
         [0099]    Subjects used the test materials as instructed and completed a weekly questionnaire after each week of use. 
         [0100]    After the 4-week use period, subjects returned the test materials and weekly use evaluations and responded to a computerized questionnaire. 
       Questionnaires 
       [0101]    Final questionnaire responses 
         [0102]    The majority of the test population reporting an opinion indicated the following qualities or test material effects: 
         [0103]    The eye care device was easy to use. 
         [0104]    The eye care device fit on the face. 
         [0105]    The eye care device was comfortable on the face. 
         [0106]    The eye pads provided enough humidification during use. The eye care device improved the dry eye problem. 
         [0107]    The eye care device had a favorable appearance. 
         [0108]    Subjects liked the quality of the eye care device. 
         [0109]    Subjects were satisfied with the eye care device. 
         [0110]    Given the opportunity, the subjects would purchase the eye care device. 
         [0111]    The present invention may be embodied in other specific forms without departing from the spirit of the essential attributes thereof; therefore, the illustrated embodiments should be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.