Therapy delivery system having an open architecture and a method thereof

• US 8,123,717 B2
• Filed: 05/15/2008
• Issued: 02/28/2012
• 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, Thukral, Ajay, Galley, Paul, Chittajallu, Siva, Bousamra, Steven, Long, James
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US12/121,199
• Publication Number:
  US 20090005728A1
• Time in Patent Office: 1,384 Days
• Field of Search: 604/890.1, 604/891.1, 604/504, 604/503, 604 65- 67, 703/11
• 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 an operating control system having an open architecture which supports operation of the therapy delivery system and which has 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, wherein the open architecture of the operating control system provides a logical separation of the first and second control algorithm such that the first control algorithm is removable from the operating control system and replaceable by the second control algorithm without interfering with an operational functionality of hardware or software of the therapy delivery system; and

a simulation module providing a test environment which simulates at least one or more physiological conditions of the individual and enables 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, 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;

wherein the therapy dosage module comprises a failsafe module defining one or more therapy limitations independent of the first and second control algorithms which prevents delivery of therapy outside of the therapy limitations.

2. 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.

3. The therapy delivery system according to claim 2, 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.

4. 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.

5. The therapy delivery system according to claim 4, 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. The therapy delivery system according to claim 10, 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.

12. The therapy delivery system according to claim 10, 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.

13. 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.

14. 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.

15. 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.

16. The therapy delivery system of claim 1 wherein the therapy dosage module further comprises a modular utility to enhance interaction between the therapy delivery system and the individual.

17. The therapy delivery system of claim 16, wherein the modular utility provides accessibility to control algorithms.

18. The therapy delivery system of claim 16, wherein the modular utility is an event module.

19. The therapy delivery system of claim 18, wherein the event module stores data for physiological conditions of the individual.

20. The therapy delivery system of 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.

21. A therapy delivery system for an individual comprising:

a metabolic sensor which senses a metabolic parameter of the individual on an intermittent or continual basis;

an input/output interface which exchanges therapy-related data with the individual;

a therapy dosage module comprising an operating control system having an open architecture which supports operation of the therapy delivery system and which has a first control algorithm replaceable with a second control algorithm, the first and second control algorithms being defined to determine therapy for the individual, wherein the open architecture of the operating control system provides a logical separation of the first and second control algorithm such that the first control algorithm is removable from the operating control system and replaceable by the second control algorithm without interfering with an operational functionality of hardware or software of the therapy delivery system;

a therapy delivery device which delivers 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, and 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, and

wherein the therapy dosage module comprises a failsafe module defining one or more therapy limitations independent of the first and second control algorithms which prevents delivery of therapy outside of the therapy limitations.

22. The therapy delivery system of claim 21 wherein the therapy dosage module further comprises a modular utility to enhance interaction between the therapy delivery system and the individual.