Therapy management development platform

• US 8,315,885 B2
• Filed: 04/06/2010
• Issued: 11/20/2012
• Est. Priority Date: 04/14/2009
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Krogh, Ross G., Martucci, James P.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Flick, Jason
• Application Number:
  US12/754,892
• Publication Number:
  US 20110092907A1
• Time in Patent Office: 959 Days
• Field of Search: 604/151
• US Class Current: 705/2
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A method of providing therapy management development includes providing a therapy management development platform having a plurality of levels of functionality, the platform including a medical device capable of providing therapy management, setting the platform to a first level of access to the functionality relative to the medical device, and modifying the operation of the medical device using the platform. The method also includes receiving an indication of approval to change the level of access to the functionality of the platform to a second level of access, and setting the platform to the second level of access to the functionality of the platform in response to receipt of the indication of approval. The platform is also provided.

Claims

1. A method of providing therapy management development, the method comprising:

providing a computerized therapy management development platform having a plurality of levels of functionality, the computerized platform including a medical device that provides therapy management;

setting the computerized platform to a first level of access to the functionality relative to the medical device;

modifying the operation of the medical device using the computerized platform;

receiving an indication of approval to change the level of access to the functionality of the computerized platform to a second level of access;

setting the computerized platform to the second level of access to the functionality of the computerized platform in response to receipt of the indication of approval.

2. The method of claim 1, wherein each level of access corresponds to a stage in the testing of the medical device, the stage comprising one of bench trials, animal trials, human clinical trials, and human use.

3. The method of claim 2, wherein the indication of approval to change the level of access is associated with a geographic location, the method further comprising determining if the medical device is disposed in the geographic location.

4. The method of claim 1, wherein modifying the operation of the medical device comprises using the medical device with a prototype sensor or changing the operation of a control algorithm used by the medical device to control therapy management.

5. The method of claim 1, further comprising, subsequent to modifying the operation of the medical device, testing the medical device using the computerized platform.

6. The method of claim 5, wherein testing the medical device using the computerized platform comprises using virtual physiological and sensor models.

7. The method of claim 1, wherein the medical device comprises a pump and a pump controller.

8. The method of claim 1, further comprising setting a customer charge according to the level of access of the computerized platform.

9. The method of claim 1, wherein

the computerized therapy management development platform comprises:

(i) a pump controller with a pump input/output interface coupled to the pump controller,

and

(ii) an interface module including an interface module controller and a module-sensor input/output interface, the module-sensor input/output interface having at least one standardized input port, at least one standardized output port and at least one standardized power connection, and

the interface module controller customizably programmed to receive data from a sensor coupled to the module-sensor input/output interface and from the pump controller and to provide instructions to the pump controller to vary the operation of a pump coupled thereto; and

the medical device comprises one or more pumps.

10. The method according to claim 9, further comprising using a development toolkit having a graphical user interface to customizably program the interface module controller.

11. The method according to claim 10, further comprising operating the development toolkit on a computing device separate from the computerized therapy management development platform.

12. The method according to claim 11, wherein the tool kit comprises a standardized library of commands.

13. The method according to claim 9, comprising communicating wirelessly between the pump controller and the interface module via radio-frequency or infra-red transmission.

14. The method according to claim 9, wherein:

receiving an indication of approval to change the level of access to the functionality of the computerized platform comprises receiving an indication of approval associated with a geographic location for the pump controller and interface module; and

setting the computerized platform to the second level of access comprises determining if the pump controller and the interface module are disposed in the geographic location, and setting the computerized platform to the second level of access only if it is determined that the pump controller and interface module are disposed in the geographic location.

15. The method according to claim 14, wherein each level of access corresponds to a stage in the testing of a pump associated with the pump controller, the stage comprising one of bench trials, animal trials, human clinical trials, and human use.

16. The method according to claim 1, further comprising modifying the operation of the medical device using the computerized platform according to the second level of access.

17. The method according to claim 16, wherein modifying the operation of the medical device using the computerized platform, and modifying the operation of the medical device using the computerized platform according to the second level of access each comprise at least one of (i) using a prototype sensor with the medical device, (ii) making changes to the operation of a control algorithm used by the medical device to control therapy management, and a combination of (i) and (ii).

18. The method according to claim 17, wherein:

setting the computerized platform to a first level of access to the functionality relative to the medical device comprises setting the computerized platform to the first level of access according to a determination made by a first party, separate from a second party that modifies the operation of the medical device, that the second party has received approval to have access to the first level from a governmental or commercial organization that oversees testing of medical devices prior to marketing; and

setting the computerized platform to the second level of access to the functionality of the computerized platform in response to receipt of the indication of approval comprises setting the computerized platform to the second level of access according to a determination made by the first party that the second party has received approval from the governmental or commercial organization to proceed to the second level of access.

19. The method according to claim 18, wherein setting the computerized therapy management development platform to the second level of access comprises unlocking a lockout, the lockout comprising one of a software and a hardware lockout.

20. The method according to claim 19, wherein the unlocking the lockout comprises entering a password or an encryption key received from the first party.