THERAPY DELIVERY SYSTEM HAVING AN OPEN ARCHITECTURE AND A METHOD THEREOF

• US 20090005728A1
• Filed: 05/15/2008
• Published: 01/01/2009
• Est. Priority Date: 06/27/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Weinert, Stefan, Bousamra, Steven, Galley, Paul, Chittajallu, Siva, Thukral, Ajay, Long, James
• Granted Patent: US 8,123,717 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A therapy delivery system having an open architecture and method of providing thereof are disclosed. The present invention provides a therapy dosage module having a control algorithm that can be replaced with a predefined or independently defined control algorithm. The tools necessary to create and test such control algorithms in the therapy dosage module in a simulated environment before implementing it in a live therapy system are also disclosed.

Claims

1. A therapy delivery system for an individual comprising:

a therapy dosage module comprising a first control algorithm replaceable with a second control algorithm customized to needs of the individual, the first and second control algorithms being defined to determine therapy for the individual; and

a simulation module for providing a test environment simulating at least one or more physiological conditions of the individual and enabling testing of the second control algorithm when implemented in the therapy dosage module in the test environment before being used in the therapy delivery system to deliver the therapy determined by the second control algorithm to the individual.

2. The therapy delivery system according to claim 1, wherein the second control algorithm replaces the first control algorithm without interfering with an operational functionality of hardware or software of the therapy delivery system.

3. The therapy delivery system according to claim 1, wherein the first control algorithm, the second control algorithm, or both, is selectable by the individual from a predefined list of control algorithms customized to the needs of the individual.

4. The therapy delivery system according to claim 3, wherein one or more parameters of the first control algorithm, one or more parameters of the second control algorithm, or both, are modifiable to further customize the first control algorithm, the second control algorithm, or both, to the needs of the individual.

5. The therapy delivery system according to claim 1, wherein the first control algorithm, the second control algorithm, or both, is defined independently and customized to the needs of the individual.

6. The therapy delivery system according to claim 5, wherein one or more parameters of the independently defined first control algorithm, one or more parameters of the independently defined second control algorithm, or both, are modifiable to further customize the independently defined first control algorithm, the independently defined second control algorithm, or both, to the needs of the individual.

7. The therapy delivery system according to claim 1, wherein:

the testing of the second control algorithm in the simulation module comprises using the second control algorithm on a virtual patient population of the test environment, and identifying any detrimental outcomes to patient health in the virtual patient population caused by the therapy determined by the second control algorithm prior to usage in the therapy delivery system to deliver therapy to the individual.

8. The therapy delivery system according to claim 1, wherein the simulation module enables testing of both the first and second control algorithms when implemented in the therapy dosage module in the test environment.

9. The therapy delivery system according to claim 1, wherein therapy delivered to the individual by the therapy delivery system is a dosage amount, concentration, delivery rate, specific time, and/or delivery schedule of a drug determined by the first or second control algorithm.

10. The therapy delivery system according to claim 1, wherein both the first control algorithm and the second control algorithm are customized to the needs of the individual.

11. The therapy delivery system according to claim 1, wherein the therapy delivery system requires the individual to approve therapy determined by the first or second control algorithm prior to delivery of the determined therapy.

12. The therapy delivery system according to claim 1, wherein the therapy delivery system delivers therapy determined by the first or second control algorithm without requiring approval from the individual prior to delivery of the determined therapy.

13. The therapy delivery system according to claim 1, wherein the therapy delivery system further comprises an input/output interface for exchanging therapy-related data with the individual.

14. The therapy delivery system according to claim 13, wherein the input/output interface receives data relating to physiological conditions, meals, and/or activities of the individual, this received data being accessible to the first or second control algorithm in determining the therapy.

15. The therapy delivery system according to claim 13, wherein the input/output interface displays data relating to physiological conditions of the individual, meals, recommended and/or delivered therapies, and/or a list of control algorithms approved for implementation in the therapy dosage module of the therapy delivery system.

16. The therapy delivery system according to claim 1, wherein the therapy delivery system further comprises a communication module for exchanging therapy-related data with a computer, portable device, network, or other related technology.

17. The therapy delivery system according to claim 1, wherein the therapy delivery system further comprises a failsafe module defining one or more therapy limitations independent of the first and second control algorithms for substantially preventing delivery of therapy outside of the therapy limitations.

18. The therapy delivery system according to claim 1, wherein the therapy delivery system further comprises one or more metabolic sensors for sensing one or more metabolic parameters of the individual.

19. The therapy delivery system according to claim 1, wherein the therapy delivery system further comprises one or more therapy delivery devices for delivering therapy determined by the first or second control algorithm of the therapy dosage module.

20. A therapy delivery system for an individual comprising:

a metabolic sensor for sensing a metabolic parameter of the individual;

an input/output interface for exchanging therapy-related data with the individual;

a therapy dosage module comprising a first control algorithm replaceable with a second control algorithm, the first and second control algorithms being defined to determine therapy for the individual; and

a therapy delivery device for delivering the therapy determined by the first or second control algorithm of the therapy dosage module,

wherein the second control algorithm is customized to needs of the individual prior to determination of the therapy through testing of the second control algorithm in a test environment simulating at least one or more physiological conditions of the individual.

21. The therapy delivery system according to claim 20, wherein both the first control algorithm and the second control algorithm are customized to the needs of the individual prior to determination of the therapy through testing in the test environment.

22. The therapy delivery system according to claim 20, wherein the metabolic sensor senses blood glucose levels of the individual on an intermittent basis.

23. The therapy delivery system according to claim 20, wherein the metabolic sensor senses blood glucose levels of the individual on a continual basis.

24. A method of delivering therapy to an individual with a therapy delivery system, the method comprising:

defining a control algorithm for determining therapy for the individual, the control algorithm customized to needs of the individual;

providing a simulation module providing a test environment simulating at least one or more physiological conditions of the individual;

implementing the control algorithm in the test environment;

applying the control algorithm to a virtual patient population in the test environment to identify any detrimental outcomes to patient health caused by the therapy determined by the control algorithm prior to usage of the control algorithm in the therapy delivery system to deliver therapy to the individual;

modifying the control algorithm as necessary to substantially eliminate the detrimental outcomes, if any, identified by the simulation module;

implementing the control algorithm in the therapy delivery system; and

delivering therapy to the individual with the therapy delivery system, the therapy determined by the control algorithm.

25. The therapy delivery system according to claim 24, wherein the method further comprises comparing the therapy determined by the control algorithm with one or more therapy limitations independently defined by a failsafe module prior to delivery of the determined therapy to substantially prevent delivery of therapy outside of the defined therapy limitations.

26. The therapy delivery system according to claim 24, wherein the method further comprises replacing the control algorithm in the therapy dosage module with a second control algorithm further customized to the needs of the individual.