THERAPY MANAGEMENT DEVELOPMENT PLATFORM

• US 20110092907A1
• Filed: 04/06/2010
• Published: 04/21/2011
• 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: Martucci, James P., Krogh, Ross G.
• Granted Patent: US 8,315,885 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• 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 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;

modifying the operation of the medical device using the platform;

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

setting the platform to the second level of access to the functionality of the 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 platform.

6. The method of claim 5, wherein testing the medical device using the 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 platform.

9. A therapy management development platform comprising:

(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.

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

11. The platform according to claim 10, further comprising a computing device, the tool kit operating on the computing device.

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

13. The platform according to claim 9, wherein the pump controller and the interface module communicate wirelessly via radio-frequency or infra-red transmitters and receivers.

14. The platform according to claim 9, wherein the interface module receives a indication of a level of access associated with a geographic location, and determines if the pump controller and the interface module are disposed in the geographic location.

15. The platform according to claim 14, wherein the indication of the 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.