Analyte Monitoring: Stabilizer for Subcutaneous Glucose Sensor with Incorporated Antiglycolytic Agent

• US 20120330120A1
• Filed: 04/02/2012
• Published: 12/27/2012
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Ouyang, Tianmei, Liu, Zenghe, Cho, Hyun, Feldman, Benjamin J.
• Granted Patent: US 8,792,956 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

An analyte sensor including an antiglycolytic agent or a precursor thereof and a chelating agent that stabilizes the antiglycolytic agent positioned proximate to the working electrode of the sensor. Also provided are systems and methods of using the electrochemical analyte sensors in analyte monitoring.

Claims

1-39. -39. (canceled)

40. A method for monitoring a level of an analyte in a subject, the method comprising:

positioning an electrochemical sensor into skin of a subject, wherein the sensor comprises;

a working electrode comprising a sensing layer proximate thereto;

a counter electrode; and

an antiglycolytic agent or precursor thereof and a chelating agent that stabilizes the antiglycolytic agent or precursor thereof, wherein the antiglycolytic agent or precursor thereof and the chelating agent are disposed proximate to the working electrode, and

determining a level of an analyte over a period of time from signals generated by the sensor;

wherein the determining over a period of time provides for monitoring the level of the analyte in the subject.

41. The method of claim 40, wherein the analyte is glucose.

42. The method of claim 40, wherein the antiglycolytic agent is fluoride, glyceraldehyde, mannose, glucosamine, mannoheptulose, sorbose-6-phophate, or trehalose-6-phosphate.

43. The method of claim 40, wherein the antiglycolytic agent is a glyceraldehyde or a precursor thereof.

44. The method of claim 40, wherein the chelating agent is boric acid.

45. The method of claim 40, wherein the chelating agent is a transition metal.

46. The method of claim 43, wherein the glyceraldehyde or precursor thereof is present in an amount that ranges from about 1 microgram to about 2 milligrams

47. The method of claim 44, wherein the boric acid is present in an amount that ranges from about 1 microgram to about 2 milligrams.

48. The method of claim 40, wherein the sensor further comprises a membrane disposed over the sensing layer.

49. The method of claim 48, wherein the membrane comprises the antiglycolytic agent or precursor thereof and the chelating agent.

58. The method of claim 40, wherein the antiglycolytic agent or precursor thereof is chemically bonded to the chelating agent.

59. The method of claim 49, wherein the antiglycolytic agent or precursor thereof and the chelating agent are disposed on the surface of the membrane.

60. The method of claim 49, wherein the antiglycolytic agent or precursor thereof and the chelating agent are incorporated into the membrane.

50. A method for monitoring a level of an analyte in a subject, the method comprising:

contacting an antiglycolytic agent or precursor thereof and a chelating agent that stabilizes the antiglycolytic agent on an analyte determination site on skin of a subject;

positioning an electrochemical sensor into the skin of a subject at the analyte determination site, wherein the sensor comprises;

a working electrode comprising a sensing layer proximate thereto;

a counter electrode; and

determining a level over a period of time of an analyte from signals generated by the sensor;

wherein the determining over a period of time provides for monitoring the level of the analyte in the subject.

51. The method of claim 50, wherein the analyte is glucose.

52. The method of claim 50, wherein the antiglycolytic agent is fluoride, glyceraldehyde, mannose, glucosamine, mannoheptulose, sorbose-6-phophate, or trehalose-6-phosphate.

53. The method of claim 50, wherein the antiglycolytic agent is a glyceraldehyde or a precursor thereof.

54. The method of claim 50, wherein the chelating agent is boric acid.

55. The method of claim 50, wherein the chelating agent is a transition metal.

56. The method of claim 53, wherein the glyceraldehyde or precursor thereof is present in an amount that ranges from about 1 microgram to about 2 milligrams

57. The method of claim 50, wherein the sensor further comprises a membrane disposed over the sensing layer.

61. The method of claim 50, wherein the antiglycolytic agent or precursor thereof is chemically bonded to the chelating agent.

62. The method of claim 57, wherein the membrane comprises the antiglycolytic agent or precursor thereof and the chelating agent.

63. The method of claim 62, wherein the antiglycolytic agent or precursor thereof and the chelating agent are disposed on the surface of the membrane.

64. The method of claim 62, wherein the antiglycolytic agent or precursor thereof and the chelating agent are incorporated into the membrane.