Therapy management development platform

• US 10,546,101 B2
• Filed: 07/24/2015
• Issued: 01/28/2020
• Est. Priority Date: 04/14/2009
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Krogh, Ross G., Martucci, James P.
• Primary Examiner(s): Caputo, Lisa M
• Assistant Examiner(s): Hollington, Octavia
• Application Number:
  US14/808,206
• Publication Number:
  US 20150332019A1
• Time in Patent Office: 1,649 Days
• Field of Search: 604 65- 67, 604151-155, 604500-522, 6048901-8921, 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 therapy management development platform includes a pump controller coupled to an interface module. The interface module includes an interface module controller and a module-sensor input/output interface including at least one standardized input port, output port and power connection. The interface module is also customizably programmed to receive data from a sensor and to provide instructions to the pump controller to vary the operation of a pump coupled thereto according to one of a plurality of levels of functionality. Upon receipt of an indication of approval from a remote computer to change the level of access to the functionality of the platform, the interface module may be customizably programmed to receive different data from the sensor, to provide different instructions to the pump controller, or both, the approval corresponding to a stage in testing of a medical device.

Claims

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

providing a computerized therapy management development platform including at least (i) a pump controller including a first processor, and (ii) an interface module including (a) a second processor, (b) a pump controller module input/output interface, and (c) a module-sensor input/output interface, the interface module coupled to the pump controller via the pump controller module input/output interface;

performing one or both of;

(a) coupling a sensor-under-test to the module-sensor input/output interface, the sensor-under-test unapproved for therapeutic use; and

(b) programming the pump controller with an algorithm-under-test, the algorithm-under-test unapproved for therapeutic use;

setting the computerized therapy management development platform to a first level of access to facilitate a first stage of testing of the sensor-under-test and/or the algorithm-under-test, the first level of access providing first functionality;

testing one or more aspects of the sensor-under-test and/or the algorithm-under-test and receiving testing results; and

setting the computerized therapy management development platform to a second level of access, in response to an indication of approval to perform a second stage of testing, to facilitate the second stage of testing of the sensor-under-test and/or the algorithm-under-test, the second level of access providing second functionality different from, but possibly inclusive of, the first functionality.

2. The method according to claim 1, wherein performing one or both of (a) and (b) comprises performing (a).

3. The method according to claim 2, further comprising changing the operation of a control algorithm.

4. The method according to claim 1, wherein performing one or both of (a) and (b) comprises performing (b).

5. The method according to claim 4, wherein programming the pump controller with the algorithm-under-test comprises programming the controller using a development toolkit configured to permit a program to be written by a user through the manipulation of a GUI in combination with a library of standardized input commands, output commands, and procedure commands.

6. The method according to claim 1, wherein the sensor-under-test and/or the algorithm-under-test are being tested for integration with a commercial product already existing at the time that the testing occurs.

7. The method according to claim 1, wherein performing one or both of (a) and (b) comprises performing (a) and (b).

8. The method according to claim 1, further comprising setting the computerized therapy management development platform to a third level of access, in response to a second indication of approval, to facilitate a third stage of testing of the sensor-under-test and/or the algorithm-under-test, the third level of access providing third functionality different from, but possibly inclusive of, the second functionality.

9. The method according to claim 8, wherein the second indication of approval indicates regulatory approval and wherein the third functionality facilitates use of the sensor-under-test and/or the algorithm-under-test in a commercial product.

10. The method according to claim 1, wherein the interface module may be customizably programmed to receive different data from the sensor-under-test, to provide different instructions to the pump controller to vary the operation of the pump, or both.

11. The method according to claim 1, wherein the indication of approval is an encryption key, the interface module programmed to change the level of access in response to receipt of the encryption key from a remote computer.

12. The method according to claim 1, wherein:

receiving the indication of approval comprises receiving an indication of approval associated with a geographic location for the pump controller and interface module; and

setting the computerized therapy management development 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 therapy management development 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.

13. The method according to claim 1, wherein:

setting the computerized therapy management development platform to the first level of access comprises setting the computerized therapy management development 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 a medical device, that the second party has received approval from a governmental or commercial organization that oversees testing of medical devices prior to marketing to have access to the first level; and

setting the computerized therapy management development platform to the second level of access in response to receipt of the indication of approval comprises setting the computerized therapy management development platform to the second level 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.