MODULAR PHYSIOLOGIC MONITORING SYSTEMS, KITS, AND METHODS

• US 20150335288A1
• Filed: 07/31/2015
• Published: 11/26/2015
• Est. Priority Date: 06/06/2013
• Status: Abandoned Application

• Current Assignee: LifeLens Technologies, LLC
• Original Assignee: Tricord Holdings, LLC
• Inventors: Toth, Landy, Schwartz, Robert
• Application Number:
  US14/815,251
• Publication Number:
  US 20150335288A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• 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 5/14517 for sweat
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6839 Anchoring means, e.g. barbs
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6844 Monitoring or controlling distance between sensor and tissue

Abstract

Systems, devices, methods, and kits for monitoring one or more physiologic and/or physical signals from a subject are disclosed. A system including patches and corresponding modules for wirelessly monitoring physiologic and/or physical signals is disclosed. A service system for managing the collection of physiologic data from a customer is disclosed. An isolating patch for providing a barrier between a handheld monitoring device with a plurality of contact pads and a subject is disclosed.

Claims

1. A patch interface, comprising:

a substrate with a surface;

an adhesive coupled to the substrate formulated for attachment to the skin of a subject;

an interconnect embedded into or coupled to the substrate for attachment of the patch to a microcircuit; and

a plurality microelectrodes attached to or embedded into the surface of the substrate, the microelectrodes arranged, configured, and dimensioned to interface with the subject when the adhesive is attached thereto, the microelectrodes electrically coupled with at least one of the interconnect and the microcircuit;

wherein the patch interface is configured to monitor neural activity from the skin of the subject.

2. The patch interface in accordance with claim 1, wherein the adhesive is patterned onto the substrate so as to form one or more exposed regions of the substrate, one or more of the plurality of microelectrodes arranged within the exposed regions;

and wherein the adhesive comprises one of an electrically conducting and an ionically conducting component.

3. The patch interface in accordance with claim 1, wherein the adhesive provides a macroelectrode function comprising one or more macroelectrodes for interfacing with the subject when attached thereto, the one or more macroelectrodes electrically coupled to at least one of the interconnect and the microcircuit.

4. The patch interface in accordance with claim 3, wherein the one or more macroelectrodes provide at least one of a guard function, a reference function, and a counter electrode function for one or more of the microelectrodes.

5. The patch interface in accordance with claim 1, wherein one or more of the plurality of microelectrodes is configured to penetrate into the skin when the adhesive is attached to the subject.

6. The patch interface in accordance with claim 1, wherein one or more of the plurality of microelectrodes has a needle-like shape, the microelectrode comprising an insulated region and an exposed region.

7. The patch interface in accordance with claim 6, wherein a given one of the plurality of microelectrodes has a length such that the exposed region is positioned within at least one of an epidermal layer, a dermal layer, and a hypodermal layer of the skin upon attachment of the patch to the surface thereof.

8. The patch interface in accordance with claim 6, wherein one or more of the plurality of microelectrodes is shaped so as to penetrate down a root of a follicle to reach at least one of a sweat gland, a sebaceous gland, a muscle, a vessel, and an arrector pili follicular muscle upon attachment of the patch interface to the skin.

9. The patch interface in accordance with claim 1, wherein one or more of the plurality of microelectrodes comprises an electrode feature arranged so as to improve the electrical connection between the microelectrode or an exposed region thereof and the skin upon placement on a subject;

and wherein the improved electrical connection is achieved after pressure is applied to the microelectrode.

10. The patch interface in accordance with claim 1, wherein the microcircuit comprises a switch bank and an amplifier comprising two or more inputs, the switch bank adaptably configurable to couple one or more of the plurality of microelectrodes with an input of the amplifier, and couple one or more alternative ones of the plurality of microelectrodes and the one or more macroelectrodes to another input of the amplifier.

11. The patch interface in accordance with claim 10, wherein the switch bank is adaptively configurable to connect one or more clusters of the plurality of microelectrodes to a single input of the amplifier.

12. The patch interface in accordance with claim 1, wherein one or more of the plurality of microelectrodes are configured and shaped so as to penetrate into the skin during engagement therewith one of less than 3 mm, less than 2 mm into the skin, less than 1 mm, less than 0.5 mm, and less than 0.2 mm.

13. The patch interface in accordance with claim 1, wherein one or more of the plurality of microelectrodes and exposed regions thereof has an active surface area of one of less than 4 mm², less than 1 mm², less than 100,000 um², less than 10,000 um², less than 1,000 um², and less than 100 um².

14. The patch interface in accordance with claim 3, wherein the one or more macroelectrodes has an active surface area of one of greater than 5 mm², greater than 50 mm², greater than 100 mm², and greater than 500 mm².

15. The patch interface in accordance with claim 14, wherein the one or more macroelectrodes is shaped and patterned on the substrate so as to reduce movement artifacts, monitor a macroscopic electrophysiologic field, provide a reference electrode function, provide a guard electrode function, provide a drive electrode function, or a combination thereof during use.

16. The patch interface in accordance with claim 1, further comprising a sensor coupled with the substrate, and electrically coupled with the microcircuit, the sensor configured to monitor one or more physiologic parameters of the subject when coupled thereto.

17. The patch interface in accordance with claim 16, wherein the sensor comprises an electrophysiologic sensor, a temperature sensor, a thermal gradient sensor, a barometer, an altimeter, an accelerometer, a gyroscope, a humidity sensor, a magnetometer, an inclinometer, an oximeter, a colorimetric monitor, a sweat analyte sensor, a perfusion sensor, a galvanic skin response sensor, a hydration sensor, an interfacial pressure sensor, a flow sensor, a stretch sensor, a microphone, or a combination thereof.

18. The patch interface in accordance with claim 1, further comprising a stimulating device selected from an electrical stimulator, a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device, a tactile stimulating component, a vibratory stimulating element, or a combination thereof arranged along the substrate so as to interface with the skin of the subject when the adhesive is attached thereto.

19. The patch interface in accordance with claim 18, further comprising a feedback sensor coupled with the stimulating device, configured and arranged so as to monitor the interaction of the stimulating device with the skin during activation thereof.

20. The patch interface in accordance with claim 1, further comprising one or more stretchable electrically conducting traces attached to the substrate, arranged so as to couple one or more sensors, microelectrodes, and macroelectrodes with one of the interconnect and the microcircuit.

21. The patch interface in accordance with claim 1, wherein the patch interface is sufficiently physically frail such that it cannot retain a predetermined shape in a free standing state.

22. The patch interface in accordance with claim 21, further comprising a temporary stiffening member attached to the substrate, the temporary stiffening member configured to provide retention of the shape of the patch interface prior to attachment to the subject, the stiffening member being removable from the substrate after attachment to the subject.

23. The patch interface in accordance with claim 1, wherein the substrate is formed from a soft pseudo-elastic material and the patch interface is configured to maintain operation when stretched to one of more than 25%, more than 50%, and more than 80%.

24. The patch interface in accordance with claim 1, wherein the patch interface is configured with a moisture vapor transmission rate of one of:

between 200 g/m²/24 hrs and 20,000 g/m²/24 hrs;

between 500 g/m²/24 hrs and 12,000 g/m²/24 hrs; and

between 1,000 g/m²/24 hrs and 8,000 g/m²/24 hrs.

25. The patch interface in accordance with claim 1, wherein the adhesive includes one of an endothermic-reactive specie, an exothermic-reactive specie, a local analgesic, a neuro-blocker, a neurotoxin, a neural antagonist, and a neural agonist.

26. A module, comprising:

a housing;

a circuit board comprising one or more microcircuits, the circuit board coupled to the housing; and

a module interconnect coupled to one or more of the microcircuits configured for placement and coupling of the module onto a patch interface, the patch interface comprising;

a substrate with a surface;

an adhesive coupled to the substrate formulated for attachment to the skin of a subject;

an interconnect embedded into or coupled to the substrate for attachment of the patch to a microcircuit; and

a plurality microelectrodes attached to or embedded into the surface of the substrate, the microelectrodes arranged, configured, and dimensioned to interface with the subject when the adhesive is attached thereto, the microelectrodes electrically coupled with at least one of the interconnect and the microcircuit;

wherein the module is configured to monitor one or more physiologic signals, physical signals, skin based neural activity, and electrophysiological signals from the subject.

27. The module in accordance with claim 26, wherein the module comprises at least one of:

one or more sensors; and

one or more microelectronics, configured to interface with a sensor included on the patch interface, at least one of the one or more sensors comprising at least one of;

an electrophysiologic sensor, a temperature sensor, a thermal gradient sensor, a barometer, an altimeter, an accelerometer, a gyroscope, a humidity sensor, a magnetometer, an inclinometer, an oximeter, a colorimetric monitor, a perfusion sensor, a sweat analyte sensor, a galvanic skin response sensor, an interfacial pressure sensor, a flow sensor, a stretch sensor, and a microphone.

28. The module in accordance with claim 26 further, comprising a stimulating device selected from an electrical stimulator, a thermoregulating device, a heating coil, a thermoelectric device, a Peltier device, a tactile stimulating component, a vibratory stimulating element, or a combination thereof arranged along the substrate so as to interface with the skin of the subject when coupled to the patch interface.

29. The module in accordance with claim 26, wherein the module is hermetically sealed.

30. The module in accordance with claim 26, further comprising a gasket coupled to the circuit board, the gasket shaped so as to isolate the region formed by the module interconnect and the patch from a surrounding environment, when the module is coupled with the patch.