High energy radiation insensitive analyte sensors

• US 8,895,252 B2
• Filed: 03/10/2011
• Issued: 11/25/2014
• Est. Priority Date: 03/16/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Petisce, James R.
• Primary Examiner(s): UNDERDAHL, THANE E
• Application Number:
  US13/580,628
• Publication Number:
  US 20130189720A1
• Time in Patent Office: 1,356 Days
• Field of Search: None
• US Class Current: 435/7.1
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements

Abstract

Enzyme based analyte sensors having radiation stabilizing agents are disclosed and described. More particularly, devices comprising a radiation stabilizing agent and methods for stabilizing sensors to high energy radiation sterilization are disclosed and described.

Claims

1. An enzyme-based analyte sensor comprising at least one enzyme and at least one non-fugitive radiation stabilizing agent

wherein the radiation stabilizing agent comprises at least one of a hindered amine light stabilizer, a polymeric hindered phenol, a polymeric aromatic amine, a polymer with thioester or phosphorous containing appendages, a polymeric hydroxyl amine, a polymeric benzofuranone derivative, and polymeric acrylated bis-phenol,

wherein the molecular weight of the radiation stabilizing agent is greater than about 1000 Daltons and the radiation stabilizing agent is present in an amount sufficient to stabilize the activity of the at least one enzyme when the sensor is subjected to high energy radiation.

2. The enzyme-based analyte sensor of claim 1, wherein the hindered amine light stabilizer comprises one or more of polymethylpropyl 3-oxy-[4(2,2,6,6 tetramethyl) piperidinyl]siloxane (Uvasil 299);

poly[[.beta.-[1,1,3,3-tetramethyl butyl)amino]-s-triazine-2,4-diyl][[2,2,6,6-tetramethyl-4-piperidyl)imino]-hexamethylene[(2,2,6,6,-tetramethyl-4-piperidyl)imino]] (Chimassorb

     944);

dimethyl succinate polymer with 4-hydroxy-2,2,6,6-tetramethyl-1-piperidineethanol (Tinuvin

     622);

poly((6-((1,1.3.3-tetramethylbutyl)amino)-s-triazine-2,4-diyl)(t-(2,2,6,6-tetramethyl-4-piperidyl)iminohexa-methylene((2,2,6,6-tetramethyl-4-piperidyl)imino)) and dimethyl succinate polymer with 4-hydroxy 2,2,6,6-tetramethyl-1-piperidineethanol (Tinuvin

     783);

polymer of dimethyl succinate and 4-hydroxy-2,2,6,6-tetramethyl-1-piperidine ethanol (Lowilite

     62).

3. The enzyme-based analyte sensor of claim 1 or 2, further comprising an interference layer.

4. The enzyme-based analyte sensor of claim 3, wherein the interference layer comprises the at least one radiation stabilizing agent.

5. The enzyme-based analyte sensor of claim 1 or 2 comprising a flux limiting membrane.

6. The enzyme-based analyte sensor of claim 5, wherein the flux limiting membrane comprises the at least one radiation stabilizing agent.

7. The enzyme-based analyte sensor of claim 1, wherein the enzyme based analyte sensor is configured for a catheter.

8. The enzyme-based analyte sensor of claim 1, wherein the enzyme is presented in an enzyme layer, the enzyme layer comprising a hydrophilic polymer.

9. The enzyme-based analyte sensor of claim 8, wherein the hydrophilic polymer comprises at least one of a poly-N-vinylpyrrolidone, a poly-N-vinyl-3-ethyl-2-pyrrolidone, a poly-N-vinyl-4,5-dimethyl-2-pyrrolidone, a polyvinylimidazole, a poly-N—

N-dimethylacrylamide, a polyacrylamide, and copolymers thereof.

10. The enzyme-based analyte sensor of claim 8, wherein the hydrophilic polymer is poly-N-vinylpyrrolidone.

11. The enzyme-based analyte sensor of claim 8, wherein the enzyme is glucose oxidase, the hydrophilic polymer is poly-N-vinylpyrrolidone, and the enzyme layer comprises the at least one radiation stabilizing agent.

12. The enzyme-based analyte sensor of claim 1 or 2 comprising a flux limiting membrane and an interference layer.

13. The enzyme-based analyte sensor of claim 12 wherein the flux limiting membrane, interference layer or both comprise the at least one radiation stabilizing agent.