Personal diagnostic devices including related methods and systems

• US 9,133,024 B2
• Filed: 09/02/2004
• Issued: 09/15/2015
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Life Patch International Incorporated
• Original Assignee: Life Patch International Incorporated
• Inventors: Phan, Brigitte Chau, Pal, Andrew Atilla, Valencia, Ramoncito M., Bollella, Donald
• Primary Examiner(s): FORMAN, BETTY J
• Application Number:
  US10/934,665
• Publication Number:
  US 20050106713A1
• Time in Patent Office: 4,030 Days
• Field of Search: None
• US Class Current: 1/1
• 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

A personal diagnostic patch device for biological analysis includes a sample acquisition layer for obtaining a fluid sample, a fluidic processing layer including a fluidic circuit for directing fluid flow, an assay results detection layer having a detector for detecting diagnostic results derived from fluid sample analysis, and a processor and transmitter for sending diagnostic results to a remote location. The layers are situated in register with each other and operatively attached with constituent elements in alignment to form the fluidic circuit for sample processing, detection, and analysis. Related systems include a remotely located user computer for receiving a signal from the patch device when the device is provided with the transmitter. The user computer may be connected to a network including any one or more of several different medical providers. Methods include use of the patch device for specific applications, related processes, and steps for manufacturing and assembling.

Claims

1. A personal diagnostic device for analysis of a fluid sample, comprising:

a sample acquisition layer for obtaining a fluid sample from a user, said sample acquisition layer being associated with a light source;

a fluidic processing layer in fluid communication with said sample acquisition layer and configured to process said fluid sample, said fluidic processing layer including a fluidic circuit configured to direct said fluid sample to an analysis chamber, said fluidic circuit containing different chambers for sample processing, detection, and analysis;

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

a signal processing layer, a controller layer, and an input/output layer including a display configured to display at least some of said diagnostic results of said fluid sample after analysis, and said sample acquisition layer, said fluidic processing layer, and said assay results detection layer are in register with each other and are operatively attached to each other to form said fluidic circuit, and said light source, analysis chamber, and detector are in register with each other such that light emitted from said light source passes through said analysis chamber and is detectable by said detector.

2. The device according to claim 1 further comprising at least one chamber containing a pressurized gas.

3. The device according to claim 1 further comprising at least one chamber containing 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 sound emitter for providing said user with feedback.

7. The device according to claim 1 further comprising a logic processing system.

8. The device according to claim 7 further comprising an Internet Protocol address within said logic processing.

9. The device according to claim 1 further comprising an air sample acquisition member for obtaining and testing an air sample from the ambient environment of a user.

10. The device according to claim 7 wherein said logic processing system has TCP/IP.

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

12. The device according to claim 7 wherein said logic processing system generates output information regarding a medical state of the user.

13. The device according to claim 12 further comprising a memory for storing said output information.

14. The device according to claim 1 further comprising a receiver, and a controller associated said controller layer wherein a return command from a first remote location is received by said receiver, and processed by said processor and said controller to thereby activate a desired functionality within the device.

15. The device according to claim 1 further configured to perform a cellular assay.

16. The device according to claim 1 further configured to perform a small molecule assay.

17. The device according to claim 1 further configured to perform a glucose assay.

18. The device according to claim 1 further configured to perform a stress assay.

19. The device according to claim 1 further configured to perform a cortisol assay.

20. The device according to claim 1 further configured to perform an enzyme assay.

21. The device according to claim 1 further configured to perform a lactate assay.

22. The device according to claim 1 further configured to perform a cardiac marker assay.

23. The device according to claim 1 further configured to perform a creatinine assay.

24. The device according to claim 1 further configured to perform a hemoglobin assay to detect anemia.

25. The device according to claim 1 further comprising tubules, lancets, or microprobes configured to draw up blood or fluid samples for testing.

26. The device according to claim 25 further comprising an anticoagulant in said tubules, lancets, or microprobes.

27. The device according to claim 25 further comprising programmable valves to flush out any old blood accumulated at tips of said tubules, lancets, or microprobes.

28. The device according to claim 1 further comprising a transmitter operatively associated with a processor and a memory, said transmitter enabled to wirelessly transmit an electronic signal including at least some information about said diagnostic results from said personal diagnostic device to a remote location.

29. The device according to claim 28 further configured to interface with a computer device remotely maintained from said personal diagnostic device, said computer device including a receiver for receiving said electronic signal so that said at least some of said information about said diagnostic results is thereby transferred from said personal diagnostic device to said computer device for further processing.

30. The device according to claim 28 further comprising a logic processing system operatively associated with said processor and implemented within said personal diagnostic device to control operational functions of said personal diagnostic device.

31. The device according to claim 30 further comprising an address within said logic processing system so that said device is addressable remotely over a network.

32. The device according to claim 28 wherein said detector includes a charged coupled device (CCD) for detecting electro-magnetic energy after interaction thereof with said diagnostic results.

33. The device according to claim 28 wherein said detector includes at least one light receiving nano-wire for detecting electro-magnetic energy after interaction thereof with said diagnostic results.

34. The device according to claim 28 wherein said detector includes at least one light receiving micro-wire for detecting said electro-magnetic energy after interaction thereof with said diagnostic results.

35. The device according to claim 28 wherein said detector includes a semi-conductor light detecting material for detecting said electro-magnetic energy after interaction thereof with said diagnostic results.

36. The device according to claim 29 wherein said computer device includes a monitor and said at least some of said information about said diagnostic results is displayed on said monitor.

37. The device according to claim 28 wherein said computer device is a desk top computer.

38. The device according to claim 29 wherein said computer device is a lap top computer.

39. The device according to claim 29 wherein said computer device is a hand-held computer.

40. The device according to claim 29 further comprising a receiver operatively associated with said processor for accepting a control command signal from said computer device.

41. The device according to claim 29 wherein said computer device is linked to a network and said network is further linked to a medical provider'"'"'s computer system so that said information about said diagnostic results is accessible by a medical provider at a remote location.

42. The device according to claim 40 wherein said computer device is linked to a network and said network is further linked to a medical provider'"'"'s computer system so that a medical provider at a remote location is thereby enabled to send said control command to said personal diagnostic device.

43. The device according to claim 28 further comprising a plurality of remote receivers implemented within a respective physical environment to wirelessly receive said electronic signal from said personal diagnostic device, said remote receivers linked to a network and said network further linked to a medical provider'"'"'s computer system so that said at least some of said information about said diagnostic results is accessible by a medical provider at a remote location.

44. The device according to claim 43 further comprising a receiver implemented within said personal diagnostic device operatively associated with said processor for accepting a control command signal from said medical provider'"'"'s computer system.

45. The device according to claim 43 further comprising a logic processing system operatively associated with said processor and implemented within said personal diagnostic device to control operational functions therein.

46. The device according to claim 45 further comprising a drug-release reservoir having supply probes that penetrate into said user and said logic processing system includes logic and control functionality to release a pre-determined amount of liquid medication from a 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.

47. The device according to claim 46 wherein said drug-release reservoir is subdivided into a pre-selected number of sub-reservoirs each having a pre-determined amount of said liquid medication stored therein so that said amount of 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.

48. The device according to claim 46 wherein said liquid medication includes a hormone.

49. The device according to claim 48 wherein said hormone is insulin.