TISSUE-INTEGRATING ELECTRONIC APPARATUS

• US 20140357964A1
• Filed: 08/15/2014
• Published: 12/04/2014
• Est. Priority Date: 05/27/2010
• Status: Active Grant

• Current Assignee: Profusa, Inc.
• Original Assignee: Profusa, Inc.
• Inventors: Wisniewski, Natalie A., Helton, Kristen, Petersen, Kurt E., McMillan, William A.
• Granted Patent: US 10,010,272 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

Tissue-integrating electronic apparatuses, systems comprising such apparatuses and methods of using these apparatuses and systems for the detection of one or more signals are provided.

Claims

1. An apparatus comprising:

a tissue-integrating scaffold including a flexible wire; and

a sensor operatively coupled to the flexible wire and integrated with the scaffold, the sensor configured to produce a detectable signal.

2. The apparatus of claim 1, wherein the flexible wire is formed from at least one of Au, Pd, Pt, Ag, Cu, Al, aluminum alloys, Ni, Zn, Cr, Ti, W, doped amorphous or polycrystalline silicon, Mo, Ta, carbon, an aligned tissue or a conductive polymer.

3. The apparatus of claim 1, wherein the sensor comprises at least one of a light source, a detector, a temperature sensor, an accelerometer, a pressure sensor, a magnetic sensor, or a piezoelectric sensor.

4. The apparatus of claim 3, wherein the light source comprises an LED.

5. The apparatus of claim 1, wherein the scaffold further comprises a polymeric material.

6. The apparatus of claim 5, wherein the polymeric material comprises at least one of an insulating polymer or a conductive polymer.

7. The apparatus of claim 1, wherein the scaffold comprises an e-textile coated with a polymeric material.

8. The apparatus of claim 7, wherein the polymeric material comprises at least one of an insulating polymer or a conductive polymer.

9. The apparatus of claim 1, further comprising one or more sensing moieties embedded within the scaffold.

10. The apparatus of claim 1, further comprising one or more sensing moieties attached to an exterior portion of the scaffold.

11. The apparatus of claim 10, further comprising a coating exterior to the one or more sensing moieties.

12. The apparatus of claim 1, wherein the scaffold is porous and at least two pores of the scaffold are interconnected.

13. The apparatus of claim 12, wherein the mean diameter of the pores is between about 1 micrometers and about 100 micrometers.

14. The apparatus of claim 12, wherein the mean diameter of the pores is between about 10 micrometers and about 90 micrometers.

15. The apparatus of claim 12, wherein the mean diameter of the pores is about 30 micrometers.

16. The apparatus of claim 1, wherein the sensor includes a plurality of perforations.

17. The apparatus of claim 16, wherein the mean diameter of the plurality of perforations is at least about 100 micrometers.

18. The apparatus of claim 1, wherein the apparatus includes one or more layers.

19. The apparatus of claim 1, wherein the apparatus includes one or more fibers.

20. A method, comprising:

integrating an apparatus according to claim 1 into a tissue of a subject and detecting the presence of an analyte.

21. A system, comprising:

an apparatus according to claim 1; and

an implantable module configured to measure the signal produced by the apparatus.

22. The system of claim 21, further comprising at least one of a power source, electrical control circuitry, a detector, a signal receiver, a signal transmitter, a signal processor, a data storage component, a data transmitter, a data processor or a display.

23. The system of claim 21, further comprising an external apparatus having at least one of a power source, a signal receiver, a signal processor, a data processor, memory for storing data or a display.

24. The system of claim 21, wherein the module is operably connected to the apparatus by a flexible wire.

25. An apparatus, comprising:

a tissue-integrating scaffold including a flexible wire;

a tissue-integrating electrode coupled to the flexible wire; and

the flexible wire being configured to conduct at least one electrical signal flowing through the tissue-integrating electrode, the at least one electrical signal being associated with an amount of an analyte.

26. The apparatus of claim 25, wherein the tissue-integrating electrode is at least one of a tissue-integrating working electrode, a tissue-integrating counter electrode or a tissue-integrating reference electrode.

27. The apparatus of claim 25, wherein the tissue-integrating electrode is one of a plurality of tissue-integrating electrodes connected in series.

28. The apparatus of claim 25, wherein the tissue-integrating electrode is one of a plurality of tissue-integrating electrodes connected in parallel.

29. The apparatus of claim 25, wherein the tissue integrating electrode includes an enzyme layer including at least one of an oxidase or a dehydrogenase.

30. The apparatus of claim 25, wherein the tissue integrating electrode includes an enzyme layer including at least one of glucose oxidase, lactate oxidase, pyruvate oxidase, ethanol oxidase, histamine oxidase or bilirubin oxidase.

31. The apparatus of claim 25, wherein the flexible wire is formed from at least one of Au, Pd, Pt, Ag, Cu, Al, aluminum alloys, Ni, Zn, Cr, Ti, W, doped amorphous or polycrystalline silicon, Mo, Ta, carbon, an aligned tissue or a conductive polymer.

32. The apparatus of claim 25, further comprising at least one of a temperature sensor, an accelerometer, a pressure sensor, a magnetic sensor or a piezoelectric sensor.

33. The apparatus of claim 25, wherein the scaffold comprises a polymeric material.

34. The apparatus of claim 33, wherein the polymeric material comprises at least one of an insulating polymer or a conductive polymer.

35. The apparatus of claim 25, wherein the scaffold comprises an e-fabric coated with a polymeric material.

36. The apparatus of claim 35, wherein the polymeric material comprises at least one of an insulating polymer or a conductive polymer.

37. The apparatus of claim 25, wherein the scaffold is porous and at least two pores of the scaffold are interconnected.

38. The apparatus of claim 37, wherein the mean diameter of the at least two pores is between about 1 micrometers and about 100 micrometers.

39. The apparatus of claim 37, wherein the mean diameter of the pores is between about 10 micrometers and about 90 micrometers.

40. The apparatus of claim 37, wherein the mean diameter of the pores is about 30 micrometers.

41. The apparatus of claim 25, wherein the apparatus comprises one or more layers.

42. The apparatus of claim 25, wherein the apparatus comprises one or more fibers.

43. A method, comprising:

integrating an apparatus according to claim 25 into the tissue of the subject; and

detecting the presence of an analyte.

44. A system, comprising:

an apparatus according to claim 25; and

a tissue-integrating module operably connected to the apparatus, the tissue-integrating module being configured to apply a test voltage to the tissue-integrating electrode and to measure an electrical signal flowing through the tissue-integrating electrode.

45. The system of claim 44, wherein the tissue-integrating module further comprises at least one of a power source, a voltage source, electrical control circuitry, a signal receiver, signal processor, a data transmitter or a data processor.

46. The system of claim 44, further comprising an external apparatus having at least one of a power source, a signal receiver, a signal processor, a data processor, memory for storing data or a display.

47. The system of claim 44, wherein the tissue-integrating module is operably connected to the apparatus by the flexible wire.

48. An apparatus, comprising:

a tissue-integrating scaffold including a flexible wire;

a tissue-integrating electrode embedded in the tissue-integrating scaffold, the tissue-integrating electrode having a substrate onto which is disposed at least one of an electrochemically conductive layer, an inner selective membrane layer, an enzyme layer or an outer diffusion limiting membrane; and

wherein the flexible wire is electrically connected to the tissue-integrating electrode and is configured to conduct at least one electrical signal flowing through the tissue-integrating electrode, wherein the at least one electrical signal is indicative of an amount of an analyte within the apparatus.

49. The apparatus of claim 48, wherein the tissue-integrating electrode is one of a tissue-integrating working electrode, a tissue-integrating counter electrode or a tissue-integrating reference electrode.

50. The apparatus of claim 48, wherein the tissue-integrating electrode is one of a plurality of tissue-integrating electrodes connected in series.

51. The apparatus of claim 48, wherein the tissue-integrating electrode is one of a plurality of tissue-integrating electrodes connected in parallel.

52. The apparatus of claim 48, wherein the enzyme layer includes at least one of an oxidase or a dehydrogenase.

53. The apparatus of claim 48, wherein the tissue integrating electrode includes an enzyme layer including at least one of glucose oxidase, lactate oxidase, pyruvate oxidase, ethanol oxidase, histamine oxidase or bilirubin oxidase.

54. The apparatus of claim 48, wherein the flexible wire is formed from at least one of Au, Pd, Pt, Ag, Cu, Al, aluminum alloys, Ni, Zn, Cr, Ti, W, doped amorphous or polycrystalline silicon, Mo, Ta, carbon, an aligned tissue or a conductive polymer.

55. The apparatus of claim 48, further comprising at least one of a temperature sensor, an accelerometer, a pressure sensor, a magnetic sensor, or a piezoelectric sensor.

56. The apparatus of claim 48, wherein the scaffold comprises a polymeric material.

57. The apparatus of claim 56, wherein the polymeric material comprises at least one of an insulating polymer or a conductive polymer.

58. The apparatus of claim 48, wherein the scaffold comprises an e-fabric coated with a polymeric material.

59. The apparatus of claim 58, wherein the polymeric material comprises at least one of an insulating polymer or a conductive polymer.

60. The apparatus of claim 48, wherein the scaffold is porous and at least two of the pores of the scaffold are interconnected.

61. The apparatus of claim 60, wherein the mean diameter of the at least two pores is between about 1 micrometers and about 100 micrometers.

62. The apparatus of claim 60, wherein the mean diameter of the pores is between about 10 micrometers and about 90 micrometers.

63. The apparatus of claim 60, wherein the mean diameter of the pores is about 30 micrometers

64. The apparatus of claim 48, wherein the apparatus comprises one or more layers.

65. The apparatus of claim 48, wherein the apparatus comprises one or more fibers.

66. A method, comprising:

integrating the apparatus according to claim 48 into a tissue of a subject and detecting the presence of an analyte.

67. A system, comprising:

an apparatus according to claim 48; and

a tissue-integrating module operably connected to the apparatus, the tissue-integrating module being configured to apply at least one test voltage and to measure at least one electrical signal flowing through the tissue-integrating electrode.

68. The system of claim 67, wherein the tissue-integrating module further comprises at least one of a power source, a voltage source, electrical control circuitry, a signal receiver, signal processor, a data transmitter or a data processor.

69. The system of claim 67, further comprising an external apparatus having at least one of a power source, a signal receiver, a signal processor, a data processor, memory for storing data or a display.

70. The system of claim 67, wherein the tissue-integrating module is operably connected by one or more flexible wires.