Wireless footswitch and functional electrical stimulation apparatus

• US 9,597,497 B2
• Filed: 10/22/2012
• Issued: 03/21/2017
• Est. Priority Date: 10/27/2011
• Status: Active Grant

• Current Assignee: Salisbury NHS Foundation Trust
• Original Assignee: Salisbury NHS Foundation Trust
• Inventors: Nolan, Dominic Scott, Batty, Robert Peter, Swain, Ian Douglas, Finn, Stacey Michael
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US14/352,569
• Publication Number:
  US 20140276236A1
• Time in Patent Office: 1,611 Days
• US Class Current: 1/1
• CPC Class Codes: A43B 17/00 Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
• CPC Class Codes: A43B 3/0031 provided with a pocket, e.g. for keys or a card
• CPC Class Codes: A43B 3/34 with electrical or electronic arrangements
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/1038 Measuring plantar pressure during gait
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/6807 Footwear
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment

Abstract

A shoe insole has a cavity configured to provide an internal pocket open to a face of said insole, conveniently the lower face, the cavity having a length greater than its width and being directed generally along the length of the insole. A segmented structure is slideably insertable into said cavity within it is removably retained, the segments being disposed along the cavity and housing a pressure sensor, sensor state monitoring circuits, a wireless transceiver and a battery, adjacent segments being electrically connected together and hinged together by pairs of laterally spaced connector bars each mechanically connected together by links configured to maintaining the spacing between segments while permitting flexion between adjacent segments under loads encountered during walking.

Claims

1. A shoe insole for use in functional electrotherapy having a cavity opening to its lower face and a wireless footswitch module located in said cavity, wherein said footswitch module comprises:

a load, force or pressure sensor;

a microcontroller for receiving signals from the sensor indicating phase of walking and having a power-saving mode in which a microprocessor or core forming part of said microcontroller can be disabled while inputs continue to be active;

a wireless transceiver in communication with the microcontroller for transmitting sensor state information;

a battery for providing power; and

an accelerometer for monitoring user activity/inactivity and controlling entry of the microcontroller into working and power-saving modes;

wherein the accelerometer is a 3-axis accelerometer having FIFO technology for minimising host processor load, has low power or standby modes for intelligent motion-based power management and has an SPI digital interface for providing output data.

2. The shoe insole of claim 1, wherein the wireless transceiver is configured to operate according to a ZigBee protocol.

3. The shoe insole of claim 1, wherein the cavity is configured to provide a pocket within said insole having an opening to the lower face of the insole into which the wireless footswitch module is slideably insertable and within which pocket it is retained until removed.

4. The shoe insole of claim 3, wherein the cavity has a length greater than its width and is directed generally along the longitudinal direction of the insole, and wherein the module is a segmented structure is disposed in said cavity with its segments extending along the cavity and holding the sensor, sensor state monitoring circuits, wireless transceiver and battery, adjacent segments being electrically connected together and mechanically connected together by links configured to maintain the spacing between segments while permitting flexion between adjacent segments under loads encountered during walking.

5. The shoe insole of claim 4, wherein one of said segments is positioned to underlie the arch of the foot and holds the sensor state monitoring circuits and transmitter, a second segment which holds the sensor is positioned to underlie the heel of the foot or to underlie the ball of the foot and a third segment holds the battery which is a coin cell.

6. The shoe insole of claim 5, wherein the sensor is a pressure-sensitive resistor an open-circuit resistance of ≧

100 KΩ

with no load applied, falling below about 5 KΩ

under load, the sensor having an active portion comprising an array of fingers in contact with a conductive pad so that mechanical pressure urging the pad towards the fingers reduces the resistance of the sensor.

7. The shoe insole of claim 6, wherein the sensor comprises:

a first insulating plastics sheet formed with a head region and relatively narrow lead-defining extensions;

conductive metal in a pattern on the plastics sheet defining an inter-digitated array connected to leads extending along said lead-defining extensions;

a second insulating plastics sheet having a head conforming to the head region of the first insulating plastics sheet, and having stub projections for covering proximal regions of the lead-defining extensions of the first plastics sheet;

a layer of semiconductive material on the second insulating plastics sheet, the second insulating plastics sheet having a surface with a texture or roughness or content of conductive material such that when pressed against the electrodes of the array it forms an connection between the fingers of the opposed sides of the array; and

an adhesive layer securing the first and second plastics sheets together.

8. The shoe insole of claim 7, wherein leads of the sensor extend from the sensor segment into the active component segment and are held in contact with a circuit board forming part of said active component segment by an elastomeric member in compression.

9. The shoe insole of claim 8, wherein the elastomeric member comprises a block of silicone elastomer.

10. The shoe insole of claim 1, further comprising:

first and second electrodes for attachment to a body to apply an electrical stimulus; and

a transceiver communicating with the microcontroller and providing the electrical stimulus via the first and second electrodes in response to information received from the transceiver.

11. An electrical stimulator for attachment to a body, comprising:

first and second electrodes for attachment to the body to apply an electrical stimulus;

a shoe insole for use in functional electrotherapy having a cavity opening to its lower face and a wireless footswitch module located in said cavity, wherein said footswitch module comprises a load, force or pressure sensor, a microcontroller for receiving signals from the sensor indicating phase of walking and having a power-saving mode in which a microprocessor or core forming part of said microcontroller can be disabled while inputs continue to be active, a wireless transceiver in communication with the microcontroller for transmitting sensor state information, a battery for providing power and an accelerometer for monitoring user activity/inactivity and controlling entry of the microcontroller into working and power-saving modes; and

a transceiver forming part of the simulator for communicating with the insole and providing the electrical stimulus via the first and second electrodes in response to information received from the insole;

wherein the accelerometer is a 3-axis accelerometer having FIFO technology for minimizing host processor load, has low power or standby modes for intelligent motion-based power management and has an SPI digital interface for providing output data.

12. The electrical stimulator of claim 11, wherein:

the cavity is configured to provide a pocket within said insole having an opening to the lower face of the insole into which the wireless footswitch module is slideably insertable and within which pocket it is retained until removed.

13. The electrical stimulator of claim 12, wherein:

the cavity has a length greater than its width and is directed generally along the longitudinal direction of the insole, and wherein the module is a segmented structure is disposed in said cavity with its segments extending along the cavity and holding the sensor, sensor state monitoring circuits, wireless transceiver and battery, adjacent segments being electrically connected together and mechanically connected together by links configured to maintain the spacing between segments while permitting flexion between adjacent segments under loads encountered during walking; and

one of said segments is positioned to underlie the arch of the foot and holds the sensor state monitoring circuits and transmitter, a second segment which holds the sensor is positioned to underlie the heel of the foot or to underlie the ball of the foot and a third segment holds the battery which is a coin cell.

14. The electrical stimulator of claim 11, wherein the sensor is a pressure-sensitive resistor an open-circuit resistance of ≧

100 KΩ

with no load applied, falling below about 5 KΩ

under load, the sensor having an active portion comprising an array of fingers in contact with a conductive pad so that mechanical pressure urging the pad towards the fingers reduces the resistance of the sensor.

15. The electrical stimulator of claim 11, wherein the sensor comprises:

a first insulating plastics sheet formed with a head region and relatively narrow lead-defining extensions;

conductive metal in a pattern on the plastics sheet defining an inter-digitated array connected to leads extending along said lead-defining extensions;

a second insulating plastics sheet having a head conforming to the head region of the first insulating plastics sheet, and having stub projections for covering proximal regions of the lead-defining extensions of the first plastics sheet;

a layer of semiconductive material on the second insulating plastics sheet, the second insulating plastics sheet having a surface with a texture or roughness or content of conductive material such that when pressed against the electrodes of the array it forms an connection between the fingers of the opposed sides of the array; and

an adhesive layer securing the first and second plastics sheets together, wherein leads of the sensor extend from the sensor segment into the active component segment and are held in contact with a circuit board forming part of said active component segment by a block of silicone elastomer or other elastomeric member in compression.

16. A wireless footswitch for use in functional electrotherapy comprising in combination:

a removable shoe insole comprising a single cavity configured to provide an internal pocket open to a face of said insole at an opening, the cavity having a length greater than its width and being directed generally along the length of the insole; and

a single segmented structure having a length greater than its width and configured for slidable insertion through said opening in said face of said sole endwise into said cavity, said structure being inserted into said cavity within which it is removably retained;

the segments being disposed along the cavity and housing a pressure sensor, sensor state monitoring circuits, a wireless transmitter and a coin cell battery;

adjacent segments being electrically connected together and being mechanically connected together by flexible hinge links configured to maintain the spacing between segments while permitting flexion between adjacent segments under loads encountered during walking; and

the single segmented structure having first, second and third segments disposed in a linear chain wherein a first segment houses the pressure sensor, a second segment located in a middle of said first, second and third segments houses the sensor state monitoring circuits and wireless transmitter and a third segment holds the coin cell battery.

17. The wireless footswitch of claim 16, wherein the sensor is a pressure-sensitive resistor having an array of fingers in contact with a conductive pad so that mechanical pressure urging the pad towards the fingers reduces the resistance of the sensor and comprising:

a first insulating plastics sheet formed with a head region and relatively narrow lead-defining extensions;

conductive metal in a pattern on the plastics sheet defining an inter-digitated array connected to leads extending along said lead-defining extensions;

a second insulating plastics sheet having a head conforming to the head region of the first insulating plastics sheet, and having stub projections for covering proximal regions of the lead-defining extensions of the first plastics sheet;

a layer of semiconductive material on the second insulating plastics sheet, the second insulating plastics sheet having a surface with a texture or roughness or content of conductive material such that when pressed against the electrodes of the array it forms an connection between the fingers of the opposed sides of the array; and

an adhesive layer securing the first and second plastics sheets together, leads of the sensor extending from the sensor segment into the active component segment and being held in contact with a circuit board forming part of said active component segment by a block of silicone elastomer or other elastomeric member in compression.

18. A wireless footswitch for use in functional electrotherapy comprising in combination:

a removable shoe insole comprising a single cavity configured to provide an internal pocket open to a face of said insole at an opening, the cavity having a length greater than its width and being directed generally along the length of the insole; and

a single segmented structure having a length greater than its width and configured for slideable insertion through said opening in said face of said sole endwise into said cavity;

the segments being disposed along the cavity and housing a pressure sensor, sensor state monitoring circuits, a wireless transmitter, and a coin cell battery;

adjacent segments being electrically connected together and being mechanically connected together by links configured to maintain the spacing between segments while permitting flexion between adjacent segments under loads encountered during walking, said links being either strap connectors behaving as living hinges or a pair of laterally spaced connector bars, each connector bar providing links maintaining the spacing between segments while permitting flexion and rotation between the adjacent segments under loads encountered during waking; and

the segmented structure having first, second and third segments disposed in a linear chain wherein a first segment houses the pressure sensor, a second segment located in a middle of said first, second and third segments houses the sensor state monitoring circuits and wireless transmitter and a third segment holds the coin cell battery.