Device and Method for Preventing Diabetic Complications

• US 20100268043A1
• Filed: 11/04/2008
• Published: 10/21/2010
• Est. Priority Date: 11/07/2007
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Shapira, Gali, Yodfat, Ofer
• Application Number:
  US12/741,715
• Publication Number:
  US 20100268043A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/6865 Access ports
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Methods, systems and devices for preventing diabetic complications are provided. In some embodiments, methods, systems and devices can be implemented using at least one subcutaneously insertable element, the element having a proximal portion and a distal portion, the proximal portion coupled to the housing, the distal portion configured for subcutaneous placement within a human body; a plurality of electrodes coupled to the distal portion of the at least one subcutaneously insertable element; and, a processor adapted to correlate a signal received from the plurality of electrodes to a concentration of ketone in the human body.

Claims

1-46. -46. (canceled)

47. A ketone management device comprising:

at least one subcutaneously insertable element, the element having a proximal portion and a distal portion, the proximal portion coupled to a housing, the distal portion configured for subcutaneous placement within a human body;

a plurality of electrodes coupled to the distal portion of the at least one subcutaneously insertable element;

at least one of the plurality of electrodes being covered by an immobilized enzyme 3-hydroxybutyrate dehydrogenase (HBDH); and

a processor adapted to correlate a signal received from the plurality of electrodes to a concentration of ketone in the human body.

48. The device of claim 47, wherein the processor is wirelessly connected to the plurality of electrodes.

49. The device of claim 47, wherein the processor is additionally adapted to correlate the signal received from the plurality of electrodes to a concentration of glucose in the human body.

50. The device of claim 47, wherein the plurality of electrodes comprises a first electrode having a first exposed surface that is at least partially coated with the immobilized enzyme 3-HBDH and a second electrode having a second exposed surface that is substantially free of the electrochemical reagent.

51. The device of claim 50, wherein the enzyme 3-HBDH undergoes a chemical reaction with analyte bodies, the chemical reaction producing a measurable voltage or current differential between the first electrode and the second electrode.

52. The device of claim 50, wherein the processor is provided in a remote control.

53. The device of claim 52, wherein the remote control unit comprises an HbA1c measurement device.

54. The device of claim 47, wherein the processor is configured to generate a notification of impending diabetic ketoacidosis based on the signals received from the plurality of electrodes.

55. The device of claim 47, wherein the device is adapted for continuous monitoring of the concentration of ketone in a subcutaneous compartment of the human body.

56. The device of claim 55, wherein the continuous monitoring is accomplished by performing discrete measurements via at least one of a high measurement rate and short inter-measurement intervals.

57. The device of claim 47, wherein the at least one subcutaneously insertable element is configured for monitoring ketone concentration levels in the subcutaneous tissue and another subcutaneously insertable element is configured for continuously dispensing insulin to the subcutaneous tissue.

58. The device of claim 50, wherein the concentration of ketone in the human body is determined based on an enzymatic dehydrogenation to acetoacetate by 3-hydroxybutyrate dehydrogenase (HBDH), followed by the detection of the reduced form of nicotinamide adenine (NADH).

59. The device of claim 58, wherein the generated NADH is further recycled to NAD+ by salicyclate hydroxylase (SHL).

60. The device of claim 47, wherein the at least one subcutaneously insertable element includes glucose oxidase (GOX).

61. The device of claim 47, wherein the at least one of the plurality of electrodes comprising a plurality of layers that modulate the diffusion of multiple analytes in the subcutaneous tissue.

62. The device of claim 47, wherein the at least one subcutaneously insertable element comprises a single cannula configured for both monitoring ketone levels in the subcutaneous tissue and dispensing insulin into the subcutaneous tissue.

63. The device of claim 47, further comprising a pump.

64. The device of claim 47, further comprising a means for alerting of unsuccessful insertion of an infusion set of an insulin pump.

65. The device of claim 64, wherein the means for alerting of unsuccessful insertion of the infusion set operates upon reaction of the immobilized enzyme with blood in the ISF.

66. The device of claim 64, wherein the infusion set includes the at least subcutaneously insertable element, the at least one subcutaneously insertable element further includes the mean for alerting of unsuccessful insertion thereon.