SYSTEMS, DEVICES AND METHODS TO DELIVER BIOLOGICAL FACTORS OR DRUGS TO A SUBJECT

• US 20110208156A1
• Filed: 02/11/2011
• Published: 08/25/2011
• Est. Priority Date: 02/11/2010
• Status: Active Grant

• Current Assignee: Sansum Diabetes Research Institute, Regents of the University of California (University of California)
• Original Assignee: Sansum Diabetes Research Institute, Regents of the University of California (University of California)
• Inventors: Zisser, Howard, Doyle, Francis J. III, Grosman, Benyamin, Javanovic, Lois, Dassau, Eyal
• Granted Patent: US 8,762,070 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A method, computer implemented method and associated apparatus for the management of diabetes is provided.

Claims

1. A method of continuous monitoring and delivery of a drug or biological agent to a subject comprising:

obtaining values associated with blood levels of a drug or biological agent for a subject;

mapping the data using a transfer function;

generating a linear difference model comprising a plurality of states;

obtaining a defined value zone for the drug or biological agent in the subject;

calculating a next administration dose and/or time of delivery of the drug or biological agent based on a predicted drug or biological agent value using the linear difference model and the defined zone;

delivering the drug or biological agent to the subject based upon the calculated next administration.

2. The method of claim 1, wherein the drug or biological agent is insulin or an insulin analogue.

3. The method of claim 2, wherein the value data comprises insulin and glucose levels.

4. The method of claim 1, wherein the method treats diabetes.

5. The method of claim 2:

wherein the obtaining values comprises obtaining insulin and meal data values and continuous glucose monitoring (CGM) data values for the subject;

mapping the insulin (I) and meal (M) data values using transfer functions;

6. The method of claim 5, wherein the delivery of insulin varies temporally and by dose.

7. The method of claim 5, wherein the delivery of insulin is a continuous or discrete infusion.

8. The method of claim 1 or 5, wherein the next administration is performed by a drug or insulin delivery pump or device.

9. The method of claim 1 or 5, wherein the next administration is performed by a computerized implanted drug or insulin pump.

10. The method of claim 5, wherein the insulin comprises an insulin or insulin analog.

11. The method of claim 5, wherein maximum glucose levels following each meal are maintained within the glycemic zone.

12. The method of claim 5, wherein the CGM data is episotic glucose measurements or self-monitoring measurements.

13. The method of claim 5, wherein the glucose measurement is obtained subcutaneously, intravenously, intraperitoneally, or noninvasively.

14. The method of claim 5, wherein the CGM data is obtain from a sensor taken from the group of sensors consisting essentially of an implanted glucose sensor, an optical glucose sensor, enzymatic glucose sensor and a finger stick glucose sensor.

15. The method of claim 1 or 5 implemented by a computer, wherein the drug, biological agent or insulin is delivered to the subject by an automated pump.

16. An insulin pump system comprising a controller that implements an automated method of claim 1 or 5, wherein an insulin or insulin analog is delivered to a subject by the pump.