Device for Interstitial Fluid Extraction, Production Process Thereof and Analyzing Process of Interstitial Fluid Using the Device

A production process of a device for interstitial fluid extraction, comprising providing a base material formed from a synthetic resin film;

• arranging a pressure sensitive adhesive layer on one surface of the base material;
• arranging a hydrogel layer formed by irradiating a coating film of an aqueous solution of at least one hydrophilic polymer selected from the group consisting of polyvinyl alcohol and polyvinyl pyrrolidone with radiation to crosslink the hydrophilic polymer on the surface of the pressure sensitive adhesive layer;
• and
• covering exposed surfaces of both pressure sensitive adhesive layer and hydrogel layer with a release layer, wherein
• the hydrogel layer has an area of a size that the pressure sensitive adhesive layer is exposed from around the hydrogel layer, does substantially not contain a sodium ion and causes no water separation when measured according to the measuring method described in the present description.

A device for interstitial fluid extraction, by which an interstitial fluid is extracted in a hydrogel layer through the skin of a vertebrate subjected to a permeability-improving treatment on the basis of a difference in osmotic pressure, and which comprises

• a base material formed from a synthetic resin film;
• a pressure sensitive adhesive layer arranged on one surface of the base material;
• a hydrogel layer arranged on the surface of the pressure sensitive adhesive layer and formed from at least one hydrophilic polymer selected from the group consisting of polyvinyl alcohol and polyvinyl pyrrolidone;
• and
• a release layer covering exposed surfaces of both pressure sensitive adhesive layer and hydrogel layer, wherein
• the hydrogel layer contains an osmotic pressure control agent, does substantially not contain a sodium ion, and satisfies, assuming that the concentration of the hydrophilic polymer is b % by weight, and the osmolarity of the osmotic pressure control agent is a osmole(s), the relationship represented by the following expression (A):
• a≦0.1b−0.6 (A)
• (however, 0.05≦a≦0.94, and 7≦b≦30).