Skin-contact product having moisture and microclimate control

Abstract

Skin-contact products with a transpiration function such as medical devices or medicinal products, of which face masks, aspirators, ventilators, breast pumps or wound dressings are examples are described especially a skin-contact product with a transpiration function with an improved microclimate at a patient interface material-skin contact area. In an embodiment a material system ( 10, 20, 30 ) is described that comprises a hydrophobic silicone base material ( 11, 21, 31 ) and a hydrophilic silicone material ( 12, 22, 32 ) that is combined with the hydrophobic base material ( 11, 21, 31 ). At least a part of the hydrophilic material ( 12, 22, 32 ) is in contact with a moist surface ( 50 ). The hydrophobic base material ( 11, 21, 31 ) provides mechanical and dynamical stability of the material system ( 10, 20, 30 ). The hydrophilic material ( 12, 22, 32 ) allows for uptake or for diffusion of moisture away from moist surface ( 50 ). The material system ( 10, 20, 30 ) is utilized to fabricate a patient interface material ( 41 ) and forehead pad ( 42 ) of a user or patient interface, such as face mask ( 40 ), for example, a patient interface mask for positive air pressure therapy. Furthermore, a novel composition for the preparation of hydrophilic silicone materials, suitable for use in the material system ( 10, 20, 30 ), is disclosed.

1 . A user interface adapted for use in a system for communicating a flow of gas with a user, the user interface comprising:
 a user contacting assembly ( 41 ) having a first portion, wherein the first portion comprises:   (a) a support material ( 11 ,  21 ,  31 ), and   (b) a contact structure comprising moisture uptake means ( 12 ,  22 ,  32 ) that is non-releasably combined with and supported by the support material ( 11 ,  21 ,  31 ), wherein the contact structure is adapted so that the moisture uptake means at least partially contacts a skin surface of a user responsive to the user interface being worn by such a user wherein the support material provides mechanical and dynamical stability for the moisture uptake means ( 12 ,  22 ,  32 ), and wherein the moisture uptake means allows for uptake or diffusion of moisture from a skin surface of a user over which the patient contacting assembly is disposed, wherein said moisture uptake means comprises a hydrophilic material, or a hydrophilic and hydrophobic material, wherein said hydrophilic material is a rubber material that takes up at least 5% by weight of water, preferably more than 10% by weight of water and particularly preferably up to 120, 200, 250 or 500% by weight of water after immersion in demineralized water at room temperature for a sufficient time such as 5 days or more to reach saturation.   
     
     
         2 . The user interface of  claim 1 , further comprising a second support portion, the first portion being operatively coupled to the support portion. 
     
     
         3 . The user interface of  claim 2 , further comprising a gas communication port located in the second support portion. 
     
     
         4 . The user interface of  claim 1 , further comprising a seal for forming a gas exchange sealing contact with skin ( 50 ) of a user. 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . The user interface of  claim 1 , wherein the hydrophilic material is any of: hydrophilic silicone, polyvinylpyrrolidones (usually with a number average molecular weight from 20,000 to 400,000), poly(hydroxyethyl methacrylates), polyethylene glycols (usually with a number average molecular weight from 200 to 10,000), polyvinyl alcohols (usually with a number average molecular weight from 10,000 to 150,000), polyacrylamides, alkali metal poly(meth)acrylates (such as, but not limited to, sodium polyacrylate, potassium polyacrylate, sodium polymethacrylate, potassium polymethacrylate), and mixtures thereof. 
     
     
         11 . The user interface of  claim 1 , wherein:
 said hydrophilic material is a hydrophilic silicone material, and wherein the hydrophobic material is a hydrophobic silicone material.   
     
     
         12 . The user interface of  claim 1 ,
 wherein said support material is a hydrophobic material ( 11 ,  21 ,  31 ) that forms a base layer;   wherein said hydrophilic material is a hydrophilic silicone ( 12 ,  22 ,  32 ) that forms a first layer disposed over the base layer; and   wherein said first layer is adapted to be disposed against the skin of a user responsive to the user interface being worn by such a user.   
     
     
         13 . The user interface of  claim 1 , wherein said hydrophilic material ( 12 ,  22 ,  32 ) is mixed into said support material, said support material being a hydrophobic material ( 11 ,  21 ,  31 ) to form a composite mixture. 
     
     
         14 . The user interface of  claim 13 ,
 wherein a layer ( 211 ) of hydrophobic material ( 21 ) is formed at an outside of said composite mixture;   wherein said layer ( 211 ) is perforated forming apertures ( 24 ); and   wherein said apertures ( 24 ) are for contacting said hydrophilic material ( 12 ,  22 ,  32 ) with the skin of a person.   
     
     
         15 . The user interface of  claim 1 ,
 wherein said support material is a hydrophobic material ( 11 ,  21 ,  31 ) that includes a plurality of holes ( 34 ) positioned at an interface ( 35 ) of said hydrophobic material ( 11 ,  21 ,  31 ) for contacting the skin of a person;   wherein said holes ( 34 ) are filled with said hydrophilic material ( 12 ,  22 ,  32 ); and   wherein said hydrophilic material ( 12 ,  22 ,  32 ) is for contact with the skin of a person.   
     
     
         16 . The user interface of  claim 1 , wherein the user interface comprises a forehead pad ( 42 ) and/or a nose/mouth cushion. 
     
     
         17 . (canceled) 
     
     
         18 . The user interface of  claim 1 , wherein said support material is stiffer than said hydrophilic material when there has been uptake of moisture in said hydrophilic material. 
     
     
         19 . The user interface of  claim 1 , wherein the user interface is a patient interface adapted for treatment of OSA or CSA. 
     
     
         20 . (canceled)