Tissue-integrating electronic apparatus

• US 10,010,272 B2
• Filed: 08/15/2014
• Issued: 07/03/2018
• Est. Priority Date: 05/27/2010
• Status: Active Grant

• Current Assignee: Profusa, Inc.
• Original Assignee: Profusa, Inc.
• Inventors: Wisniewski, Natalie A., Petersen, Kurt E., Helton, Kristen, McMillan, William A.
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US14/461,144
• Publication Number:
  US 20140357964A1
• Time in Patent Office: 1,418 Days
• Field of Search: None
• 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 fabric, tissue-integrating scaffold;

a flexible wire woven through the fabric, tissue-integrating scaffold;

an analyte-sensing, tissue-integrating electrode coupled to the flexible wire; and

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

2. An apparatus, comprising:

a tissue-integrating scaffold;

an analyte-sensing, tissue-integrating electrode; and

a flexible wire embedded within the tissue-integrating scaffold and coupled to the analyte-sensing, tissue-integrating electrode, the flexible wire being configured to conduct at least one electrical signal flowing through the analyte-sensing, tissue-integrating electrode, the at least one electrical signal being associated with an amount of an analyte.

3. The apparatus of claim 2, wherein the analyte-sensing, tissue-integrating electrode is at least one of a working electrode or a counter electrode.

4. The apparatus of claim 2, wherein the analyte-sensing tissue-integrating electrode is one of a plurality of electrodes connected in series.

5. The apparatus of claim 2, wherein the analyte-sensing, tissue-integrating electrode is one of a plurality of electrodes connected in parallel.

6. The apparatus of claim 2, wherein the analyte-sensing, tissue-integrating electrode includes an enzyme layer including at least one of an oxidase or a dehydrogenase.

7. The apparatus of claim 2, wherein the analyte-sensing, 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.

8. The apparatus of claim 2, 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.

9. The apparatus of claim 2, further comprising at least one of a temperature sensor, an accelerometer, a pressure sensor, a magnetic sensor or a piezoelectric sensor embedded within the tissue-integrating scaffold.

10. The apparatus of claim 2, wherein the tissue-integrating scaffold comprises a polymeric material.

11. The apparatus of claim 10, wherein the polymeric material comprises at least one of an insulating polymer or a conductive polymer.

12. The apparatus of claim 2, wherein the tissue-integrating scaffold comprises an e-fabric coated with a polymeric material.

13. The apparatus of claim 12, wherein the polymeric material comprises at least one of an insulating polymer or a conductive polymer.

14. The apparatus of claim 2, wherein the tissue-integrating scaffold is porous and at least two pores of the scaffold are interconnected.

15. The apparatus of claim 14, wherein the mean diameter of the at least two pores is between about 1 micrometers and about 100 micrometers.

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

17. The apparatus of claim 14, wherein the mean diameter of the pores is about 30 micrometers.

18. The apparatus of claim 2, wherein the apparatus comprises two or more layers.

19. The apparatus of claim 2, wherein the tissue integrating scaffold comprises one or more fibers.

20. A method, comprising:

implanting an apparatus according to claim 2 into tissue of the subject; and

detecting the presence of the analyte.

21. The method of claim 20, wherein the tissue is a hypodermis, a subcutis, adipose fat, a dermis, a hypodermis, or a muscle.

22. A system, comprising:

an apparatus according to claim 2; and

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

23. The system of claim 22, 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.

24. The system of claim 22, 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.

25. The system of claim 22, wherein the tissue-integrating module is operably connected to the apparatus by the flexible wire.

26. The apparatus of claim 2, wherein

the analyte-sensing, tissue-integrating electrode is embedded in the tissue-integrating scaffold, the analyte-sensing, 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

the flexible wire is electrically connected to the analyte-sensing, tissue-integrating electrode.

27. The apparatus of claim 26, wherein the tissue-integrating scaffold is a polymeric, tissue-integrating scaffold, the flexible wire embedded within the polymeric, tissue-integrating scaffold.

28. The apparatus of claim 2, wherein the tissue-integrating scaffold is a fabric, the flexible wire woven through the fabric.

29. The apparatus of claim 2, wherein the tissue-integrating scaffold is constructed entirely of a polymer.

30. The apparatus of claim 2, wherein the tissue-integrating scaffold is a sphere-templated hydrogel.

31. The apparatus of claim 2, wherein the tissue-integrating scaffold has a porosity suitable for capillaries to grow into the tissue-integrating scaffold.

32. The apparatus of claim 2, wherein the tissue-integrating scaffold defines a plurality of interconnected pores having a hallway pattern.