Device for interstitial fluid extraction, production process thereof and analyzing process of interstitial fluid using the device

• US 9,380,964 B2
• Filed: 08/26/2013
• Issued: 07/05/2016
• 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
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US13/975,854
• Publication Number:
  US 20130345597A1
• Time in Patent Office: 1,044 Days
• US Class Current: 1/1
• 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) a base material formed from a synthetic resin film comprising a polyethylene film, a polypropylene film, a polyester film or a polyurethane film;

(b) a hydrogel layer formed from at least one hydrophilic polymer selected from the group consisting of polyvinyl alcohol and polyvinyl pyrrolidone;

(c) an adhesive layer arranged between the base material and the hydrogel layer; and

(d) a release layer, wherein

(i) the hydrogel layer has a smaller surface area than a surface area of the adhesive layer whereby a portion of a surface of the adhesive layer is exposed around the hydrogel layer, (ii) the release layer covers the exposed surface of the adhesive layer and an exposed surface of the hydrogel layer, (iii) the hydrogel layer contains not more than 30 ppm sodium ion, and (iv) the hydrogel layer exhibits no water separation when the hydrogel layer is held in a flat state for 1 minute in a thermohygrostat at 23°

C. and 55% relative humidity.

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 providing the hydrogel layer with an osmolarity 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 with radiation selected from the group consisting of α

-ray, electron beam and γ

-ray to crosslink the hydrophilic polymer, said aqueous solution having a hydrophilic polymer concentration, b, 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 providing the hydrogel layer with an osmolarity, a, within a range of from 0.05 to 0.94 osmoles, and containing not more than 30 ppm sodium ion, wherein

a≦

0.1b−

0.6.

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, having an accelerating voltage within a range of from 200 kV to 10 MV and an irradiation dose 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. A process for analyzing an interstitial fluid, comprising contacting the hydrogel layer of the device for interstitial fluid extraction according to claim 1 with the skin of a vertebrate subjected to a permeability-improving treatment, extracting the interstitial fluid into the hydrogel layer, 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 a surface of the adhesive layer.

11. The device for interstitial fluid extraction according to claim 1, wherein the adhesive layer comprises an acrylic adhesive, a rubber adhesive, a silicone adhesive or a urethane adhesive.

12. The device for interstitial fluid extraction according to claim 1, wherein the adhesive layer comprises an alkyl (meth)acrylate copolymer adhesive.