Therapy delivery system having an open architecture and a method thereof

• US 8,679,087 B2
• Filed: 01/20/2012
• Issued: 03/25/2014
• 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:
  US13/354,659
• Publication Number:
  US 20120116347A1
• Time in Patent Office: 795 Days
• Field of Search: 604 65- 67, 604/500, 604/503, 604/504, 604/890.1, 604/891.1, 703/11
• US Class Current: 604/500
• 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 method of delivering therapy to an individual with a therapy delivery system, the method comprising:

defining a first control algorithm and a second control algorithm for determining therapy for the individual;

providing a therapy dosage module comprising an operating control system having an open architecture which supports operation of the therapy delivery system and which has the first control algorithm replaceable with the 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;

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

implementing the second control algorithm in the test environment;

applying the second 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 second control algorithm prior to usage of the second control algorithm in the therapy delivery system to deliver therapy to the individual;

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

implementing the second control algorithm in the therapy dosage module;

removing the first control algorithm from the operating control system and replacing the first control algorithm with the second control algorithm without interfering with an operational functionality of hardware or software of the therapy delivery system;

determining the therapy by the second control algorithm; and

delivering therapy to the individual with the therapy delivery system, the therapy determined by the second control algorithm of the therapy dosage module via a therapy delivery device.

2. The method according to claim 1, further comprises comparing the therapy determined by the second 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.

3. A method of supporting operation of a therapy delivery system which delivers therapy to an individual, the method comprising:

providing 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; and

removing the first control algorithm from the operating control system and replacing the first control algorithm with the second control algorithm without interfering with an operational functionality of hardware or software of the therapy delivery system.

4. The method according to claim 3, further comprises replacing the first control algorithm with a third or fourth control algorithm without interfering with the operational functionality of hardware or software of the therapy delivery system.

5. The method according to claim 3, further comprises providing 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;

testing the second control algorithm in the simulation module by 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.

6. The method according to claim 5, further comprises enabling the simulation module for testing of both the first and second control algorithms when implemented in the therapy dosage module in the test environment.

7. The method according to claim 3, further comprises preventing delivery of therapy outside of one or more therapy limitations wherein the therapy dosage module comprises a failsafe module defining the one or more therapy limitations independent of the first and second control algorithms.

8. The method according to claim 3, further comprises selecting by the individual from a predefined list of control algorithms customized to the needs of the individual the first control algorithm, the second control algorithm, or both.

9. The method according to claim 3, further comprises modifying one or more parameters of the first control algorithm, one or more parameters of the second control algorithm, or both, to further customize the first control algorithm, the second control algorithm, or both, to the needs of the individual.

10. The method according to claim 3, further comprises determining via the first or second control algorithm the therapy delivered to the individual by the therapy delivery system as a dosage amount, concentration, delivery rate, specific time, and/or delivery schedule of a drug.

11. The method according to claim 3, further comprises customizing both the first control algorithm and the second control algorithm to the needs of the individual.

12. The method according to claim 3, further comprises requiring the individual to approve therapy determined by the first or second control algorithm prior to delivery of the determined therapy.

13. The method according to claim 3, further comprises exchanging therapy-related data with the individual via an input/output interface.

14. The method 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 method 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 method according to claim 3, further comprises exchanging therapy-related data with a computer, portable device, network, or other related technology via a communication module.

17. The method according to claim 3, further comprises sensing one or more metabolic parameters of the individual via one or more metabolic sensors.

18. The method according to claim 3, further comprises delivering therapy determined by the first or second control algorithm of the therapy dosage module with one more therapy delivery devices.

19. A method of supporting operation of a therapy delivery system which delivers therapy to an individual, the method comprising:

sensing one or more metabolic parameters of the individual on an intermittent or continual basis via one or more metabolic sensors;

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

providing 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;

removing the first control algorithm from the operating control system and replacing the first control algorithm with the second control algorithm without interfering with an operational functionality of hardware or software of the therapy delivery system;

determining the therapy by the second control algorithm by accessing at least the one or more metabolic parameters and the therapy-related data; and

delivering the therapy determined by the second control algorithm of the therapy dosage module via a therapy delivery device.

20. The method according to claim 19, further comprises enhancing interaction between the therapy delivery system and the individual via a modular utility.

21. The method according to claim 19, further comprises customizing the second control algorithm 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.

22. The method according to claim 19, further comprises defining one or more therapy limitations wherein the therapy dosage module comprises a failsafe module independent of the first and second control algorithms which prevents delivery of therapy outside of the therapy limitations.