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

• US 20130345597A1
• Filed: 08/26/2013
• Published: 12/26/2013
• Est. Priority Date: 08/04/2009
• Status: Active Grant

• Current Assignee: Nichiban Company Limited, Sysmex Corporation
• Original Assignee: Nichiban Company Limited, Sysmex Corporation
• Inventors: Hagino, Kei, Kojima, Junko, Takezaki, Akihito, Koike, Reona, Isobe, Kazuki
• Granted Patent: US 9,380,964 B2
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: C08J 3/075 Macromolecular gels
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

A device for interstitial fluid extraction, having a base material formed from a synthetic resin film, a pressure sensitive adhesive layer, a hydrogel layer formed from at least one hydrophilic polymer selected from the group consisting of polyvinyl alcohol and polyvinyl pyrrolidone, and 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.

Claims

1. A device for interstitial fluid extraction, comprising

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 the pressure sensitive adhesive layer and the hydrogel layer, wherein

the hydrogel layer has an area of a size such that the pressure sensitive adhesive layer is exposed from around the hydrogel layer, the hydrogel layer does substantially not contain a sodium ion, and the hydrogel layer causes no water separation when measured according to the measuring method described in the present description.

2. The device for interstitial fluid extraction according to claim 1, wherein the hydrogel layer further contains an osmotic pressure control agent composed of at least one compound selected from the group consisting of potassium chloride, potassium phosphate, magnesium chloride, magnesium phosphate, calcium chloride, calcium phosphate, amino acids, urea, acetic acid, ammonia, tricine, thiamine, riboflavin, nicotinic acid amide, pyridoxine, cyanocobalamine and ascorbic acid in a proportion that an osmolarity falls within a range of from 0.05 to 0.94 osmoles.

3. The device for interstitial fluid extraction according to claim 1, wherein the hydrogel layer is formed by irradiating a coating film of an aqueous solution of the hydrophilic polymer with radiation to crosslink the hydrophilic polymer.

4. The device for interstitial fluid extraction according to claim 1, wherein the hydrogel layer is obtained by irradiating a coating film of an aqueous solution of the hydrophilic polymer, said aqueous solution having a hydrophilic polymer concentration within a range of from 7 to 30% by weight, containing an osmotic pressure control agent composed of at least one compound selected from the group consisting of potassium chloride, potassium phosphate, magnesium chloride, magnesium phosphate, calcium chloride, calcium phosphate, amino acids, urea, acetic acid, ammonia, tricine, thiamine, riboflavin, nicotinic acid amide, pyridoxine, cyanocobalamine and ascorbic acid in a proportion that an osmolarity falls within a range of from 0.05 to 0.94 osmoles, substantially containing no sodium ion, and satisfying, 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)

with radiation selected from the group consisting of α

-ray, electron beam and γ

-ray to crosslink the hydrophilic polymer.

5. The device for interstitial fluid extraction according to claim 4, wherein the hydrogel layer is obtained by irradiating the coating film of the aqueous solution of the hydrophilic polymer with electron beam, whose accelerating voltage is within a range of from 200 kV to 10 MV and whose irradiation dose is within a range of from 5 to 20,000 kGy, to crosslink the hydrophilic polymer.

6. The device for interstitial fluid extraction according to claim 1, wherein the hydrophilic polymer is polyvinyl alcohol having a saponification degree within a range of from 78 to 100 mol % and an average polymerization degree within a range of from 500 to 4,000.

7. The device for interstitial fluid extraction according to claim 1, wherein the water content in the hydrogel layer is within a range of from 70 to 95% by weight.

8. The device for interstitial fluid extraction according to claim 1, wherein the swelling rate of the hydrogel layer, which is obtained by multiplying a value obtained by dividing a weight after immersing the hydrogel layer in physiological saline for 24 hours by a weight before the immersion in the physiological saline by 100, is within a range of from 100 to 300%.

9. The device for interstitial fluid extraction according to claim 1, which is used in an analyzing process of an interstitial fluid, comprising extracting the interstitial fluid in the hydrogel layer through the skin of a vertebrate subjected to a permeability-improving treatment, analyzing the interstitial fluid collected in the hydrogel layer after a predetermined period of time has elapsed to measure the concentrations of a sodium ion and glucose contained therein and calculating out a value corresponding to a glucose concentration in the blood of the vertebrate on the basis of these measured values.

10. The device for interstitial fluid extraction according to claim 1, wherein the hydrogel layer is arranged directly or through an intermediate layer composed of a nonwoven fabric or synthetic resin film on the surface of the pressure sensitive adhesive layer.