Field optimized assay devices, methods, and systems

• US 9,268,911 B2
• Filed: 07/23/2014
• Issued: 02/23/2016
• 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., Yeager, Keith, Modena, Mario Matteo, Cadinu, Paolo, Poh, Yuk Kee Cheung, Houghtaling, Robert, Laksanasopin, Tassaneewan, Chin, Curtis D.
• Primary Examiner(s): Mehmood, Jennifer
• Assistant Examiner(s): Casillashernandez, Omar
• Application Number:
  US14/339,069
• Publication Number:
  US 20140333453A1
• Time in Patent Office: 580 Days
• Field of Search: 34087001-87044, 506/9, 705/51
• US Class Current: 1/1
• 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,

wherein the packets include the digital data in encrypted form,

wherein the medical diagnostic or treatment device comprises;

a removable cartridge with on or more microfluidic channels therein;

a pressure generating device constructed to generate a positive or negative pressure;

a storage unit comprising a reservoir that is separate from the pressure generating device and constructed to store the pressure generated by the pressure generating device;

a flow control device including a valve or sealing plug that controls flow through one or more of the microfluidic channels; and

a controller configured to control the flow control device to selectively apply the stored pressure from the storage unit to the one or more microfluidic channels so as to move a reagent and/or the biological substance through the one or more microfluidic channels,

wherein the pressure generating device is constructed to generate the pressure by manual actuation,

the reservoir is constructed to withhold the stored pressure from the cartridge until the flow control device is controlled by the controller to apply the stored pressure to the one or more microfluidic channels,

the one or more microfluidic channels comprise a first inlet for a sample, a second inlet for a reagent, a suction port, and a third inlet,

the third inlet is disposed downstream of the first and second inlets and upstream of the suction port, and

the third inlet allows air to be drawn into the one or more microfluidic channels by a negative pressure applied from the reservoir to the suction port, until the third inlet is sealed by the sealing plug of the flow control device.

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 are less than 100 bytes in size and include a patient identifier and diagnostic data.

6. 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.

7. The device of claim 6, wherein the medical diagnostic or treatment device is configured to perform an assay of a biological substance.

16. The device of claim 1, wherein:

the one or more microfluidic channels includes at least capture chamber, an inlet channel, and an outlet channel;

the capture channel is defined by at least a top wall, a bottom wall, and one or more side walls;

the inlet channel being disposed closer to the bottom wall than the top wall;

the outlet channel being disposed closer to the top wall than the bottom wall;

the medical diagnostic or treatment device further comprising;

a magnetic source disposed closer to the bottom wall than the top wall; and

a reader disposed closer to the top wall than the bottom wall; and

the controller is configured to control flow from the inlet channel through the capture chamber and out through the outlet channel such that magnetic beads in said flow through the capture chamber are retained in the capture chamber.

19. The device of claim 1, wherein the pressure generating device comprises:

a first member attached to a first portion of a positive displacement pump;

a second member movable attached to the first member and attached to a second portion of the positive displacement pump;

the first and second members being elongate with their long axes in parallel disposition;

the movement of the first and second positive displacement pump portions being effective to pump a compressible fluid into or from the reservoir of the storage unit when the first and second members are moved relative to each other.

8. A point of care communications device, comprising:

a diagnostic device comprising;

a cartridge with one or more microfluidic channels therein;

a pressure generating device constructed to generate a positive or negative pressure;

a storage unit comprising a reservoir that is separate from the pressure generating device and is constructed to store the pressure generated by the pressure generating device;

a flow control device including a valve or sealing plug that controls flow through one or more of the microfluidic channels;

a sensor configured to detect a result of an assay of a biological substance and to generate a sensor signal responsively thereto; and

a controller configured to control the flow control device to selectively apply the stored pressure from the storage unit to the one or more microfluidic channels so as to move a reagent and/or the biological substance through the one or more microfluidic channels to perform the assay;

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

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

a power source that provides electrical power to at least one of the controller, the communications device, and the communications component;

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,

wherein the communications component operates in conformance with at least one of Short-Burst Data (SBD) protocol used by Iridium satellite communications systems and Enhanced Mobile Satellite Services (EMSS) protocol used by satellite communications systems, and

the pressure generating device is constructed to generate the pressure by manual actuation without any electrical power from said power source,

the reservoir is constructed to withhold the stored pressure from the cartridge until the flow control device is controlled by the controller to apply the stored pressure to the one or more microfluidic channels,

the one or more microfluidic channels comprise a first inlet for a sample, a second inlet for a reagent, a suction port, and a third inlet,

the third inlet is disposed downstream of the first and second inlets and upstream of the suction port, and

the third inlet allows air to be drawn into the one or more microfluid channels by a negative pressure applied from the reservoir to the suction port, until the third inlet is sealed by the sealing plug of the flow control device.

17. The medical device of claim 8, wherein:

the one or more microfluidic channels includes at least a capture chamber, an inlet channel, and an outlet channel;

the capture channel is defined by at least a top wall, a bottom wall, and one or more side walls;

the inlet channel being disposed closer to the bottom wall than the top wall;

the outlet channel being disposed closer to the top wall than the bottom wall;

the diagnostic device further comprising;

a magnetic source disposed closer to the bottom wall than the top wall; and

a reader disposed closer to the top wall than the bottom wall; and

the controller is configured to control flow from the inlet channel through the capture chamber and out through the outlet channel such that magnetic beads in said flow through the capture chamber are retained in the capture chamber.

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

a diagnostic device configured to generate diagnostic data, the diagnostic device comprising;

a cartridge with one or more microfluid channels therein, the one or more microfluidic channels including at least a capture chamber, an inlet channel, and or outlet channel, the capture channel being defined by at least a top wall, a bottom wall than the top wall, and the outlet channel being disposed closer to the top wall than the bottom wall;

a magnetic source disposed closer to the bottom wall than the top wall;

a pressure generating device constructed to generate a positive or negative pressure;

a storage unit comprising a reservoir that is separate from the pressure generating device and constructed to store the pressure generated by the pressure generating device; and

a flow control device including a valve or sealing plug that controls flow through one or more of the microfluidic channels;

a controller configured to control the flow control device to selectively apply the stored pressure from the storage unit to the one or more microfluid channels so as to move fluid through the inlet channel into the capture chamber and out of the capture chamber via the outlet channel such that magnetic beads in the fluid flowing through the capture chamber are retained in the capture chamber,

the controller being programmed to receive diagnostic data from the diagnostic device and 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;

a communication device adapted for transmitting said binary data using Iridium Short Burst Data protocol; and

a power source that provides electrical power to at least one of the communication device and the controller,

wherein the pressure generating device is constructed to generate the pressure by manual actuation without any electrical power from said power source,

the valve of the flow control device controls application of the stored pressure from the reservoir to the cartridge,

the one or more microfluidic channels comprise a first inlet for a sample, a second inlet for a reagent, a suction port, and a third inlet,

the third inlet is disposed downstream of the first and second inlets and upstream of the suction port, and

the third inlet allows air to be drawn into the one or more microfluidic channels by a negative pressure applied from the reservoir to the suction port, until the third inlet is sealed by the sealing plug of the flow control device.

10. The system of claim 9, wherein said diagnostic device includes a non-volatile data store and is adapted to store said diagnostic data therein.

11. The system of claim 9, wherein:

said diagnostic device includes;

a sensor disposed closer to the top wall than the bottom wall; and

an assay platform adapted to perform an assay of a biological substance;

said sensor being arranged to detect a result of an assay, and

said diagnostic device is further configured to generate said diagnostic data responsive to a signal from said sensor which is responsive to said result of said assay.

12. 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 dataserver,

wherein the operating a portable diagnostic or treatment device comprises;

generating vacuum by applying a force to a mechanical actuator of a pressure generatingdevice of the portable diagnostic or treatment device, the force resulting from manual input to themechanical actuator without external electrical power input;

storing the generated vacuum in a vacuum chamber of the portable diagnostic or treatment device separate from a cartridge having a microfluidic circuit; and

in response to a command from a controller of the portable diagnostic or treatmentdevice, applying the vacuum stored in said vacuum chamber to the cartridge having the microfluidic circuit to transport fluid therein,

wherein the vacuum chamber is separate from the pressure generating device,

wherein the microfluidic circuit comprises one or more microfluidic channels,

the one or more microfluidic channels comprising a first inlet for a sample, a second inlet for a reagent, a suction port, and a third inlet,

the third inlet is disposed downstream of the first and second inlets and upstream of the suction port, and

the third inlet allows air to be drawn into the one or more microfluidic channels by a negative pressure applied from the reservoir to the suction port, until the third inlet is sealed by the sealing plug of the flow control devive.

13. The method of claim 12, wherein said transmitting includes employing a Short Burst Data transmission protocol.

14. The method of claim 12, wherein said transmitting includes using a Short Burst Data modem.

15. The method of claim 12, further comprising accepting a patient identifier, wherein said generating includes combining said patient identifier in said diagnostic or treatment data.

18. The method of claim 12, wherein the microfluidic circuit includes at least an inlet channel, an outlet channel, and a capture chamber, and

the applying vacuum to transport fluid in the microfluidic circuit comprises flowing fluid having magnetic beads therein through the inlet channel into the capture chamber and out of the capture chamber into the outlet channel while applying a magnetic field such that the magnetic beads in the fluid flow are retained in the capture chamber.