DISTRIBUTED NETWORK OF IN-VITRO DIAGNOSTIC DEVICES

• US 20130066563A1
• Filed: 09/09/2011
• Published: 03/14/2013
• Est. Priority Date: 09/09/2011
• Status: Active Grant

• Current Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Inventors: Hengstler, Stephan, Xie, Tong
• Granted Patent: US 9,715,579 B2
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system is disclosed in which a plurality of in-vitro diagnostic (IVD) devices each include a network communication device for connecting to a publicly accessible data network. For example, IVD devices are provided with a cellular modern for connecting to a public cellular network. These IVD devices connect to the data network upon completion of a diagnostic test, and upload results of the test, as well as other appropriate data, to a remote device which is also on the network. The IVD devices also download appropriate data from remote network elements. The remote network element may be a network element such as a Hospital Information System (HIS) or Laboratory Information System (LIS) database. Alternatively, the remote device may be a remote server or another IVD device. This connectivity enables the system to accumulate diagnostic test data, and to analyze, report, and/or update the IVD devices based on the accumulated data.

Claims

1. A diagnostic test analysis system comprising:

at least one processor;

at least one network interface device; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one network interface device to;

determine a first result of a first diagnostic test based on at least one biological sample provided by a user based on a current testing protocol,

receive additional data generated from the remote network element, and

generate a second test result based, at least in part, on the additional data.

2. The diagnostic test analysis system of claim 1, wherein:

(a) the additional data includes data indicative of an updated testing protocol which is different from the current testing protocol,

(b) the updated testing protocol is based, at least in part, on the data indicative of the first result of the first diagnostic test, and

(c) the plurality of instructions cause the at least one processor to determine the second result of the second diagnostic test based, at least in part, on the updated testing protocol.

3. The diagnostic test analysis system of claim 1, wherein the data indicative of the current testing protocol includes calibration data by which to perform at least one diagnostic test.

4. The diagnostic test analysis system of claim 1, wherein the data indicative of the current testing protocol includes a default testing protocol provided by a manufacturer.

5. The diagnostic test analysis system of claim 1, wherein the biological sample is a physiological fluid of the user.

6. The diagnostic test analysis system of claim 1, wherein the user is a medical professional, and wherein the biological sample is a physiological fluid of a patient separate from the user.

7. The diagnostic test analysis system of claim 1, wherein the publicly accessible data network is a cellular data network, and wherein the at least one network interface device includes a cellular modem.

8. The diagnostic test analysis system of claim 7, wherein the cellular data network is at least one of a 2G network, a 3G network, and a 4G network.

9. The diagnostic test analysis system of claim 2, wherein the remote network element includes a remote medical database, and wherein the updated testing protocol is also based on data from a plurality of remote in-vitro diagnostic devices.

10. The diagnostic test analysis system of claim 9, wherein the data from the plurality of remote in-vitro diagnostic devices includes a plurality of results of a plurality of diagnostic tests performed by the plurality of remote in-vitro diagnostic devices.

11. The diagnostic test analysis system of claim 10, wherein the data from the plurality of remote in-vitro diagnostic devices includes additional data, stored in association with the plurality of results of the plurality of diagnostic tests performed by the plurality of remote in-vitro diagnostic devices.

12. The diagnostic test analysis system of claim 2, wherein the plurality of instructions cause the at least one processor to determine at least a portion of the updated testing protocol upon receiving the data indicative of the updated testing protocol.

13. The diagnostic test analysis system of claim 1, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to receive at least one signal directly from a remote in-vitro diagnostic device to form an ad-hoc network of devices.

14. The diagnostic test analysis system of claim 1, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to send data indicative of the first result of the first diagnostic test to a remote network element over a publicly accessible data network.

15. The diagnostic test analysis system of claim 14, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to send the data indicative of the first result of the first diagnostic test to a remote handheld device of a remote medical professional for display to the remote medical professional.

16. The diagnostic test analysis system of claim 1, wherein the remote network element is configured to generate at least one report based on the first result of the first diagnostic test and based on a different result of a different diagnostic test performed by one of a plurality of remote in-vitro diagnostic devices.

17. The diagnostic test analysis system of claim 1, wherein the publicly accessible data network is not a short-range link selected from the group consisting of:

Bluetooth, UART, USB, WiFi, Wireless USB, or ZigBee.

18. A diagnostic test analysis system comprising:

at least one processor;

at least one network interface device; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one network interface device to;

store data indicative of a current testing protocol,

determine a first result of a first diagnostic test based on at least one biological sample provided by a user and based on the current testing protocol,

receive additional data generated from the remote network, the additional data indicative of diagnostic information pertaining to the current testing protocol, and

generate a different second result based, at least in part, on the received additional data, the different second result including a modification of the first result of the first diagnostic test based on the current testing protocol and based on the additional data.

19. The diagnostic test analysis system of claim 18, wherein the plurality of instructions cause the at least one processor to send data indicative of the first result of the first diagnostic test to a remote network element over a publicly accessible data network.

20. The diagnostic test analysis system of claim 18, wherein the data indicative of the current testing protocol includes calibration data by which to perform at least one diagnostic test.

21. The diagnostic test analysis system of claim 18, wherein the plurality of instructions cause the at least one processor to alter the current testing protocol based on the received additional data indicative of the diagnostic information.

22. The diagnostic test analysis system of claim 18, wherein the publicly accessible data network is a cellular data network, and wherein the at least one network interface device includes a cellular modem.

23. The diagnostic test analysis system of claim 19, wherein the remote network element includes a remote medical database, and wherein the updated testing protocol is also based on data from a plurality of remote in-vitro diagnostic devices.

24. The diagnostic test analysis system of claim 19, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to receive at least one signal directly from a remote in-vitro diagnostic device to form an ad-hoc network of devices.

25. A diagnostic test analysis system comprising:

at least one processor;

at least one display device;

at least one network interface device configured to enable access to at least one publicly accessible wireless data network; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate with the at least one display device and the at least one network interface device to;

determine a result of a diagnostic test based on at least one biological sample provided by a user,

automatically determine additional data based on network information of the publicly accessible wireless data network, hardware information associated with the diagnostic test analysis system, or environmental information associated with an environment in which the diagnostic test was performed,

store the additional data in association with the data indicative of the result of the diagnostic test, and

automatically send the data indicative of the result of the diagnostic test and the associated additional data to a remote network element via the publicly accessible wireless data network, the remote network element configured to combine the sent data indicative of the result of the diagnostic test and the associated additional data with sent data from a remote in-vitro diagnostic device, and to perform at least one analysis on the combined data.

26. The diagnostic test analysis system of claim 25, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to receive the additional data via the publicly accessible wireless network.

27. The diagnostic test analysis system of claim 25, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to receive data indicative of the at least one analysis on the combined data.

28. The diagnostic test analysis system of claim 26, wherein the plurality of instructions cause the at least one processor to determine a second result of a second diagnostic test based, at least in part, on the received data indicative of the at least one analysis on the combined data.

29. The diagnostic test analysis system of claim 27, wherein the at least one analysis on the combined data is performed in real-time.

30. The diagnostic test analysis system of claim 25, wherein the remote network element includes a remote in-vitro diagnostic device.

31. The diagnostic test analysis system of claim 25, wherein the remote network element includes a portable device of a medical professional selected from the group consisting of:

a personal digital assistant, a notebook computer, a netbook computer, and a mobile telephone.

32. The diagnostic test analysis system of claim 25, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to communicate directly with a remote in-vitro diagnostic device to form an ad-hoc network of devices.

33. A diagnostic test analysis system comprising:

at least one processor;

at least one network interface device;

at least one display device; and

at least one memory device which stores a plurality of instructions which, when executed by the at least one processor, cause the at least one processor to operate the at least one network interface device to;

determine a first result of a first diagnostic test based on at least one biological sample provided by a user and based on a testing protocol,

send data indicative of a connection request to a remote network element over a publicly accessible data network, the remote network element being a remote in-vitro diagnostic device,

receive a response to the connection request from the remote network element, said receipt of the response establishing an ad-hoc network connection with the remote in-vitro diagnostic device, and

after establishment of the ad-hoc network, send data representing at least a portion of the first result of the first diagnostic test to the remote in-vitro diagnostic device.

34. The diagnostic test analysis system of claim 33, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to receive at least one signal indicative of processed data resulting from processing of the sent data representing at least the portion of the first result, said processing performed by the remote in-vitro diagnostic device.

35. The diagnostic test analysis system of claim 33, wherein the publicly accessible data network enables two-way communication with the remote in-vitro diagnostic device.

36. The diagnostic test analysis system of claim 33, wherein the plurality of instructions cause the at least one processor to operate with the at least one network interface device to receive remote result data from the remote in-vitro diagnostic device, the remote result data indicative of at least one result of at least one diagnostic test performed by the remote in-vitro diagnostic device.

37. The diagnostic test analysis system of claim 36, wherein the plurality of instructions cause the at least one processor to alter at least a portion of the first diagnostic test based on the received remote result data.

38. The diagnostic test analysis system of claim 37, wherein the alteration of at least the portion of the first diagnostic test includes a recalibration of t first diagnostic test.

39. The diagnostic test analysis system of claim 37, wherein the alteration of at least the portion of the first diagnostic test includes an adjustment to at least one calculation made as a part of the first diagnostic test.