Personal diagnostic device having a fluidic circuit with a plurality of analysis chambers

• US 9,993,189 B2
• Filed: 09/14/2015
• Issued: 06/12/2018
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Life Patch International
• Original Assignee: Life Patch International
• Inventors: Phan, Brigitte Chau, Pal, Andrew Atilla, Valencia, Ramoncito M., Bollella, Donald
• Primary Examiner(s): Forman, Betty J
• Application Number:
  US14/853,523
• Publication Number:
  US 20160058354A1
• Time in Patent Office: 1,002 Days
• Field of Search: None
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/0285 Nanoscale sensors
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14521 using means for promoting sweat production, e.g. heating the skin measuring sweat secretion A61B5/4266
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150251 : Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150358 : Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 : Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150755 : Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15087 : short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 : Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/151 : Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/681 : Wristwatch-type devices
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/72 : Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/12 : Specific details about manufacturing devices
• CPC Class Codes: B01L 2200/143 : Quality control, feedback systems
• CPC Class Codes: B01L 2300/023 : Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/027 : Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/0636 : Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0681 : Filter
• CPC Class Codes: B01L 2300/069 : Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0816 : Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/0887 : Laminated structure
• CPC Class Codes: B01L 2400/049 : vacuum
• CPC Class Codes: B01L 2400/0655 : pinch valves
• CPC Class Codes: B01L 2400/0677 : phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502738 : characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 3/502746 : characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: B82Y 15/00 : Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: B82Y 30/00 : Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: G01N 33/528 : Atypical element structures, e.g. gloves, rods, tampons, toilet paper

Abstract

Personal diagnostic devices including diagnostic patches (bio-patches) and interactive medical bracelets (bio-bracelets) are provided with a skin/patch interface, at least one analysis layer, a signal processing layer, and a user output interface. Embodiments of the interactive diagnostic devices may include micro-fluidic circuits with reaction chambers, analysis chambers, mixing cambers, and various pre-disposed chemistries or reagents for performing a wide verity of tests by transdermal transport of blood or perspiration. Sample collection chambers for the fluidic circuit may include minimally invasive tubules that penetrate the skin surface to acquire blood samples from capillaries near the epidermis. Alternate implementations of the personal diagnostic device may be equipped with logic processing, input/output devices, acoustic microphones, cryogenic circuits, embedded processors, electrical control circuitry, and battery current sources or photovoltaic sources of electrical power.

Claims

1. A personal diagnostic patch device having multiple layers for analysis of a fluid sample, said personal diagnostic patch device comprising:

a patch that is configured to be worn by a user on a skin surface;

a sample acquisition layer on said patch that obtains a fluid sample from the user, said sample acquisition layer comprising a plurality of tubules, valves and collection chambers, said sample acquisition layer configured to direct at a first time, the fluid sample from a first tubule to a first sample collection chamber by controlling a first value, said sample acquisition layer further configured to direct at a second time, said fluid sample from a second tubule to a second sample collection chamber by controlling a second value, said second time occurring after said first time;

a fluidic processing layer on said patch, the fluidic processing layer in fluid communication with said plurality of sample collection chambers in said sample acquisition layer, said fluidic processing layer configured to process said fluid sample, said fluidic processing layer including a fluidic circuit comprising a plurality of analysis chambers, said fluidic circuit configured to direct said fluid sample to one or more of said plurality of analysis chambers;

an assay results detection layer on said patch, said assay results detection layer having a detector for detecting assay results derived from said processing of said fluid sample;

an output layer on said patch configured to display at least some of said assay results of said fluid sample;

said sample acquisition layer, said fluidic processing layer, and said assay results detection layer are positioned on said patch in register with each other to form a fluidic circuit; and

said one or more of said plurality of analysis chambers and said detector on said patch being in communication with each other such that said one or more of said plurality of analysis chambers is detectable by said detector.

2. The device according to claim 1 wherein said one or more of said plurality of analysis chambers comprise a pressurized gas.

3. The device according to claim 1 wherein said one or more of said plurality of analysis chambers comprise a vacuum.

4. The device according to claim 1 further comprising hydrophobic surfaces for retarding fluid flow.

5. The device according to claim 1 further comprising hydrophilic surfaces for promoting fluid flow.

6. The device according to claim 1 further comprising a logic processing system with an internet protocol address.

7. The device according to claim 1 further comprising a receiver and a transmitter to provide telemetry information regarding location of said user.

8. The device according to claim 1 wherein said signal processing unit comprises a receiver, and a controller;

a return command from a first remote location is received by said receiver and processed by said controller to thereby activate a desired functionality within said personal diagnostic device.

9. The device according to claim 1 wherein said signal processing unit wirelessly transmits an electronic signal including at least some information about said diagnostic results to a remote location.

10. The device according to claim 1 further comprising an interface that communicates with a computer device remotely maintained from said personal diagnostic device, said computer device comprising at least one of the group consisting of:

a desk top computer, a lap top computer, a hand-held computer, a receiver that receives at least some information about said diagnostic results, a receiver that receives at least some of said information about said diagnostic results wirelessly, a monitor that displays at least some of said information about said diagnostic results.

11. The device according to claim 1 wherein said signal processing unit comprises an address so that said personal diagnostic device is addressable remotely over a network.

12. The device according to claim 1 wherein said detector comprises at least one of the group consisting of:

a charged coupled device (CCD), at least one light receiving nano-wire, and a semi-conductor light detecting material.

13. The device according to claim 1 further comprising at least one drug-release reservoir having supply probes that penetrate into said user and said signal processing unit includes logic and control functionality to release a pre-determined amount of liquid medication from said at least one drug-release reservoir into said user through supply probes in response to a respective control command sent by said medical provider to said personal diagnostic device over said network.

14. The device according to claim 1 further comprising at least one drug-release reservoir that is subdivided into a pre-selected number of sub-reservoirs each having a pre-determined amount of liquid medication stored therein so that said amount of liquid medication stored in each of said sub-reservoirs is releasable at different times for administration of a time-released application of said liquid medication over an extended period of time.

15. The device according to claim 14 wherein said liquid medication includes a hormone.

16. The device according to claim 1 wherein said hormone is insulin.

17. The device according to claim 1 wherein said fluidic processing layer is between 25 microns and 500 microns thick.

18. The device according to claim 1 wherein said sample acquisition layer is 100 microns thick.

19. The device according to claim 1 wherein one or more of said plurality of sample chambers is 200 microns thick.

20. The device according to claim 1 wherein said sample acquisition layer, said fluidic processing layer, and said assay results detection are assembled together to form a patch that is worn by the user.

21. The device according to claim 1 wherein said first valve comprises a first heating element and a first melt plug, and second valve comprises a second heating element and a second melt plug wherein said sample acquisition layer controls said first valve at said first time by activating said first heating element to open said first melt plug, and wherein said sample acquisition layer controls said second valve at said second time by activating said second heating element to open said second melt plug.

22. The device according to claim 1 wherein said first valve comprises a first heating element and a first melt plug.

23. The device according to claim 1 wherein said first valve comprises dissolvable plug that is activated when it comes in contact with a liquid.

24. The device according to claim 1 wherein said first valve comprises a pinch valve.