Foam earplug with transdermal material

Abstract

A foam earplug for reception at least partially within the ear canal and including a body portion formed of resilient foam plastic material having a multiple open cell structure and having a size and shape for at least partial reception within the ear canal. A transdermal material having a particular beneficial action, and with an outer layer of the foam earplug infused with the transdermal material so that the benefits of the transdermal material is in transdermal contact with the ear canal. One example is a humectant material and, specifically, a moisturizer/lubricating material, for providing an increase to the lubrication and moisturizing in the ear canal. A second example is where the beneficial action is provided by systemic distribution such as a sleep aid, i.e., Melatonin, so that, when the earplugs are worn during sleep, the earplugs will provide a sleep aid to the wearer.

We claim: 
     
         1 . A foam earplug for reception at least partially within the ear canal, including,
 a body portion formed of resilient foam plastic material having a multiple open cell structure and having a size and shape for at least partial reception within the ear canal,   a transdermal material having a particular beneficial effect for the user of the earplug, and   an outer layer of the foam earplug infused with the transdermal material so that the transdermal material is in transdermal contact with the ear canal when the foam earplug is received at least partially within the ear canal.   
     
     
         2 . The earplug of  claim 1  wherein the transdermal material is a humectant material and specifically a moisturizer/lubricating material, received within the ear canal for providing an increase in the lubrication and moisturizing in the ear canal as compared to the resilient foam plastic material without the outer layer infused with the humectant material 
     
     
         3 . The earplug of  claim 1  wherein the transdermal material is Melatonin and received within the ear canal for providing the outer layer of foam infused with Melatonin to provide an aid in sleep as compared to the resilient foam plastic material without the outer layer infused with the Melatonin material. 
     
     
         4 . The earplug of  claim 1  wherein the transdermal material provides the beneficial effect and has at least one active ingredient, that is transferred systemically to the body of the wearer by transdermal contact with the ear canal by the outer layer of foam infused with the at least one active ingredient to provide the beneficial effect to the wearer of the earplug as compared to the resilient foam plastic material without outer layer of loam infused with the at least one active ingredient. 
     
     
         5 . The earplug of  claim 1  wherein the body portion has a size and shape to be received substantially within exterior and interior portions of the ear canal. 
     
     
         6 . The earplug of  claim 1  wherein the foamable plastic material is provided to be a slow recovery foamable material. 
     
     
         7 . The earplug of  claim 1  wherein the transdermal material is a humectant material and is, specifically, glycerin. 
     
     
         8 . The earplug of  claim 1  wherein the outer layer infused with a transdermal material has a thickness in the range of 0.1 to 40 mils. 
     
     
         9 . A method of making a foam earplug having an outer layer infused with a humectant material and specifically, a moisturizer/lubricating material, including the following steps:
 providing a mold having at least one cavity to form an earplug having a size and shape to fit at least partially within an ear canal,   providing a transdermal material having a particular beneficial effect,   coating the interior of the cavity with the transdermal material,   providing a foamable plastic material, and   placing the foamable plastic material within the coated cavity to foam to the size and shape of the cavity to form a resilient foam plastic earplug having an outer layer infused with the transdermal material.   
     
     
         10 . The method of  claim 9  wherein the foamable plastic material is provided to be a slow recovery foamable material. 
     
     
         11 . The method of  claim 9  wherein the transdermal material infused in the outer layer of foam is a humectant material and, specifically, a moisturizer/lubricating material to form an earplug having the outer layer infused with the humectant material. 
     
     
         12 . The method of  claim 11  wherein the humectant material is, specifically, glycerin. 
     
     
         13 . The method of  claim 9  wherein the transdermal material of the outer layer of foam is infused with a sleep aid material and, specifically, Melatonin to form an earplug having the outer layer infused with the Melatonin material. 
     
     
         14 . The method  claim 9  wherein the transdermal material provides the beneficial effect and has at least one active ingredient that is transferred systemically to the body of the wearer by transdermal contact with the ear canal by the outer layer of foam infused with the at least one active ingredient to provide the beneficial effect to the wearer of the earplug as compared to the resilient foam plastic material without outer layer of foam infused with the at least one active ingredient. 
     
     
         15 . The method of  claim 9  wherein the cavity is provided with a size and shape to produce an earplug to be received substantially within exterior and interior portions of the ear canal. 
     
     
         16 . The method of  claim 9  wherein the cavity is provided with a size and shape to produce an earplug to be received only within an exterior portion of the ear canal. 
     
     
         17 . The method of  claim 9  wherein the outer layer infused with humectant material is to a thickness in the range of 0.1 to 40 mils. 
     
     
         18 . The method of  claim 9  including the additional step of removing the coated earplug from the cavity and coating any portions of the earplug not coated in the cavity by spraying. 
     
     
         19 . A method of making a foam earplug having an outer layer infused with a humectant material and specifically, a moisturizer/lubricating material, including the following steps:
 providing a mold having at least one cavity to form an earplug having a size and shape to fit at least partially within an ear canal,   providing a foamable plastic material,   placing the foamable plastic material within the cavity to foam to the size and shape of the cavity to form a resilient foam plastic earplug,   removing the earplug from the cavity,   providing a transdermal material having a particular beneficial effect, and   coating the earplug with the transdermal material to form a resilient foam plastic earplug having an outer layer infused with a transdermal material.   
     
     
         20 . The method of  claim 19  wherein the foamable plastic material is provided to he a slow recovery foamable material. 
     
     
         21 . The method of  claim 19  wherein the transdermal material infused in the outer layer is a humectant material and specifically, a moisturizer/lubricating material to form an earplug having the outer layer infused with the humectant material. 
     
     
         22 . The method of  claim 20  wherein the humectant material is, specifically, glycerin. 
     
     
         23 . The method of  claim 19  wherein the transdermal material of the outer layer is a sleep aid material and, specifically, Melatonin to form an earplug having the outer layer infused with the Melatonin material. 
     
     
         24 . The method of  claim 19  wherein the transdermal material provides the beneficial effect and has at least one active ingredient that is transferred systemically to the body of the wearer by transdermal contact with the ear canal by the outer layer of foam infused with the at least one active ingredient to provide the beneficial effect to the wearer of the earplug as compared to the resilient foam plastic material without outer layer of foam infused with the at least one active ingredient. 
     
     
         25 . The method of  claim 19  wherein the cavity is provided with a size and shape to produce an earplug to be received substantially within exterior and interior portions of the ear canal. 
     
     
         26 . The method of  claim 19  wherein the cavity is provided with a size and shape to produce an earplug to be received only within an exterior portion of the ear canal. 
     
     
         27 . The method of  claim 19  wherein the outer layer infused with humectant material is to a thickness in the range of 0.1 to 40 mils. 
     
     
         28 . The method of  claim 19  wherein the coating is applied by spraying. 
     
     
         29 . A method of making a foam earplug having an outer layer infused with a humectant material and specifically, a moisturizer/lubricating material, including the following steps:
 providing a foamable plastic material,   providing a mold having a size and shape to form an elongated flat sheet of foamed plastic material,   placing the foamable plastic material within the cavity to foam to the size and shape of the cavity,   providing a punch having an interior size of an earplug to fit at least partially within an ear canal,   repeatedly punching the elongated flat sheet of foamed plastic material to form multiple earplugs each having a size and shape to fit at least partially within an ear canal,   providing a transdermal material having a particular beneficial effect, and   coating the earplug with the transdermal material to form a resilient foam plastic earplug having an outer layer infused with a transdermal material.   
     
     
         30 . The method of  claim 29  wherein the foamable plastic material is provided to be a slow recovery foamable material. 
     
     
         31 . The method of  claim 29  wherein the transdermal material infused in the outer layer is a humectant material and, specifically, a moisturizer/lubricating material to form an earplug having the outer layer infused with the humectant material. 
     
     
         32 . The method of  claim 31  wherein the humectant material is, specifically, glycerin. 
     
     
         33 . The method of  claim 29  wherein the transdermal material the outer layer is a sleep aid material and, specifically, Melatonin to form an earplug having the outer layer infused with the Melatonin material. 
     
     
         34 . The method of  claim 29  wherein the transdermal material provides the beneficial effect and has at least one active ingredient that is transferred systemically to the body of the wearer by transdermal contact with the ear canal by the outer layer of foam infused with the at least one active ingredient to provide the beneficial effect to the wearer of the earplug as compared to the resilient foam plastic material without outer layer of foam infused with the at least one active ingredient. 
     
     
         35 . The method of  claim 29  wherein the cavity is provided with a size and shape to produce an earplug to be received substantially within exterior and interior portions of the ear canal. 
     
     
         36 . The method of  claim 29  wherein the cavity is provided with a size and shape to produce an earplug to be received only within an exterior portion of the ear canal. 
     
     
         37 . The method of  claim 29  wherein the outer layer infused with humectant material is to a thickness in the range of 0.1 to 40 mils. 
     
     
         38 . The method of  claim 29  wherein the coating is applied by spraying.