FIELD OPTIMIZED ASSAY DEVICES, METHODS, AND SYSTEMS

• US 20140333453A1
• Filed: 07/23/2014
• Published: 11/13/2014
• Est. Priority Date: 01/27/2012
• Status: Active Grant

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: SIA, Samuel K., MODENA, Mario Matteo, CADINU, Paolo, YEAGER, Keith, POH, Yuk Kee Cheung, HOUGHTALING, Robert, LAKSANASOPIN, Tassaneewan, CHIN, Curtis D.
• Granted Patent: US 9,268,911 B2
• Time in Patent Office: Days
• US Class Current: 340/870.07
• CPC Class Codes: G06F 21/602 Providing cryptographic facilities or services
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: H04L 9/14 using a plurality of keys or algorithms

Abstract

A portable unitary device handheld diagnostic device can be operated with minimal power requirement and provides ease of operation as well as low cost communication of diagnostic data from remote locations. The device can provide nucleic-acid based diagnostics with minimal training, little to no sample preparation, and generates diagnostic data in about 45 minutes. A system can enable point of care transmission from any location globally using a low cost satellite-based data link technique, for example, Short Burst Data (SBD), combined with data encoding.

Claims

1. A point of care medical device, comprising:

a medical diagnostic or treatment device with at least one sensor and configured to generate digital data responsively to the at least one sensor;

the at least one sensor being adapted to detect and generate a data signal indicative of;

a result of an assay of a biological substance, a diagnostic indicator of a human, a treatment outcome, or a condition of diagnostic or treatment device;

a communications component configured to store and compress digital data that is responsive to the data signal and to wirelessly transmit said digital data; and

the communications component being configured to transmit, at transmission times, in packets of less than a kilobyte size.

2. The device of claim 1, wherein the communications component is configured to power down between transmission times.

3. The device of claim 1, wherein the communications component operates in conformance with Short-Burst Data (SBD) protocol provided by Iridium satellite communications systems.

4. The device of claim 1, wherein the communications component operates in conformance with Enhanced Mobile Satellite Services (EMSS) protocol used by satellite communications systems.

5. The device of claim 1, wherein the packets include the digital data in encrypted form.

6. The device of claim 1, wherein the packets are less than 100 bytes in size and include a patient identifier and diagnostic data.

8. The device of claim 1, further comprising:

a computer readable medium with instructions encoded thereon for encoding data including a date, a patient identifier, and diagnostic result data pertaining to a patient identified by said patient identifier in a binary encoded compressed and encrypted format.

10. The device of claim 8, wherein the medical diagnostic or treatment device is configured to perform an assay of a biological substance.

7. (canceled)

9. (canceled)

11. A point of care communications device, comprising:

a communications device adapted for connection to a diagnostic device and configured for receiving medical diagnostic data generated by said diagnostic device, the data being responsive to a sensor signal representing a result of an assay of a biological substance;

a communications component configured to store and compress digital data responsive to the received medical diagnostic data and to wirelessly transmit said digital data;

the communications component being configured to transmit, at transmission times, in packets of less than a kilobyte size in bursts;

each packet including binary data indicating a patient identifier and said digital data;

the communications component being configured to power down between transmission times.

12. The device of claim 11, wherein the communications component operates in conformance with Short-Burst Data (SBD) protocol used by Iridium satellite communications systems.

13. The device of claim 11, wherein the communications component operates in conformance with Enhanced Mobile Satellite Services (EMSS) protocol used by satellite communications systems.

14. (canceled)

15. A diagnostic system for point of care use in remote environments, comprising:

a diagnostic device configured to generate diagnostic data;

a controller programmed to receive diagnostic data from the diagnostic device and to compress and encrypt the data;

the controller being further programmed to receive patient data representing a patient corresponding to said diagnostic data;

the controller being further programmed to compress and encrypt said patient data and said diagnostic data to generate binary data; and

a communications device adapted for transmitting said binary data using Iridium Short Burst Data protocol.

16. The system of claim 15, wherein said diagnostic device includes a non-volatile data store and is adapted to store said diagnostic data therein.

17. The system of claim 15, wherein said diagnostic device includes a sensor and an assay platform and is adapted to perform an assay of a biological substance;

said sensor being arranged to detect a result of an assay, said diagnostic device being further configured to generate said diagnostic data responsive to a signal from said sensor which is responsive to said result of said assay.

18. The system of claim 17, wherein said diagnostic device includes a non-volatile data store and is adapted to store said diagnostic data in said non-volatile data store.

19. (canceled)

20. A method of providing medical data, comprising:

at a point of care location, operating a portable diagnostic or treatment device to generate diagnostic or treatment data therefrom;

generating compressed and encrypted data from said diagnostic or treatment data;

transmitting said compressed and encrypted data by a satellite to a predefined data server.

21. The method of claim 20, wherein said transmitting includes employing a Short Burst Data transmission protocol.

22. The method of claim 20, wherein said transmitting includes using a Short Burst Data modem.

23. The method of claim 20, further comprising accepting a patient identifier, wherein said generating includes combining said patient identifier in said diagnostic or treatment data.

24. The method of claim 20, wherein the operating a portable diagnostic or treatment device comprises:

generating vacuum by applying a force to a mechanical actuator of the portable diagnostic or treatment device and storing a resulting vacuum in a vacuum chamber of the portable diagnostic or treatment device, the force resulting from manual input to the mechanical actuator without external power input; and

applying vacuum stored in said vacuum chamber to a cartridge having a microfluidic circuit to transport fluid therein.

25-78. -78. (canceled)