Functional electrical stimulation systems

• US 10,543,365 B2
• Filed: 07/09/2018
• Issued: 01/28/2020
• Est. Priority Date: 05/01/2006
• Status: Active Grant

• Current Assignee: Bioness Neuromodulation Ltd.
• Original Assignee: Bioness Neuromodulation Ltd.
• Inventors: Lasko, Eyal, Springer, Shmuel, Rubin, Mark, Dar, Amit
• Primary Examiner(s): Voorhees, Catherine M
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US16/030,065
• Publication Number:
  US 20190009086A1
• Time in Patent Office: 568 Days
• CPC Class Codes: A61B 5/1038 Measuring plantar pressure during gait
• CPC Class Codes: A61H 3/00 Appliances for aiding patients or disabled persons to walk about apparatus for helping babies to walk A47D13/04; orthopaedic devices for correcting deformities of, or supporting, limbs A61F5/0102; exercising apparatus for the feet or toes A63B23/10; stairways or ramps E04F11/00
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• 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
• CPC Class Codes: G01L 1/20 by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids of piezo-resistive materials G01L1/18; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress
• CPC Class Codes: H01H 3/14 adapted for operation by a part of the human body other than the hand, e.g. by foot
• CPC Class Codes: H03K 17/9625 using a force resistance transducer

Abstract

A gait modulation system including: (a) a sensor device including a sensor adapted for associating with at least one lower limb of the patient, the sensor for transducing at least one parameter related to a gait of the patient, so as to obtain gait data related to the gait, and (b) a muscle stimulator including: (i) an electrical stimulation circuit, the circuit adapted to supply an electrical stimulation output to an electrode array for performing functional electrical stimulation of at least one muscle of the lower limb, and (ii) a microprocessor, operatively connected to the at least one sensor, the microprocessor adapted for: receiving a stream of gait information based on the gait data; processing the gait information, and controlling the stimulation output based on the processing of the gait information, and wherein the microprocessor is further adapted to identify a failure in the stream of gait information, and to consequently control the electrical stimulation circuit to deliver a fail-safe stimulation output over a portion of a duration of the failure.

Claims

1. A gait modulation system comprising:

a sensor unit including at least a sensor and a processor, the sensor configured to produce a plurality of signals, the sensor unit configured to determine a plurality of heel-on events based on a gait signal produced by the sensor unit crossing a first threshold, the sensor unit configured to determine a plurality of heel-off events based on the gait signal crossing a second threshold, the processor configured to determine a stance time between a first heel-on event from the plurality of heel-on events and a first heel-off event from the plurality of heel-off events; and

a stimulator configured to receive via a communication pathway at least one signal of the plurality of signals produced by the sensor, the stimulator configured to produce a first stimulation signal in response to the at least one signal received from the sensor via the communication pathway, the stimulator configured to determine that a failure of the communication pathway has occurred, the stimulator configured to produce a second stimulation signal at a predetermined time after the failure has occurred, the predetermined time being calculated based on the stance time, the stimulator adapted to supply at least one of the first stimulation signal or the second stimulation signal to an electrode array to perform functional electrical stimulation of at least one muscle.

2. The gait modulation system of claim 1, wherein:

the at least one signal received by the stimulator from the sensor is a wireless signal; and

the stimulator includes a receiver configured to receive the wireless signal, the failure of the communication pathway includes a failure of the receiver to receive the wireless signal.

3. The gait modulation system of claim 1, wherein:

the signal received by the stimulator from the sensor is a wireless signal; and

the failure of the communication pathway includes a failure of the sensor to transmit the wireless signal.

4. The gait modulation system of claim 1, wherein the second stimulation signal is different from the first stimulation signal.

5. The gait modulation system of claim 1, wherein the stimulator is configured to verify the at least one signal based on a unique identifier of the sensor unit.

6. The gait modulation system of claim 1, wherein:

the processor is configured to determine an average stance time based on the plurality of heel-on events and the plurality of heel-off events,

the predetermined time is calculated based on the average stance time.

7. The gait modulation system of claim 1, wherein:

the processor is configured to determine when the gait modulation system is operating in a swing phase based on the plurality of heel-on events and the plurality of heel-off events; and

the stimulator is configured to produce at least the second stimulation signal when the gait modulation system is operating in the swing phase.

8. The gait modulation system of claim 1, wherein the sensor unit is configured to produce a validation signal, the stimulator configured to receive the validation signal produced by the sensor unit via the communication pathway, the stimulator configured to detect that the communication pathway is functional when the validation signal is received.

9. The gait modulation system of claim 1, wherein:

the processor is configured to calculate the predetermined time,

the sensor configured to produce a validation signal at a time prior to the predetermined time, and

the failure of the communication pathway includes a failure of the stimulator to receive the validation signal.

10. The gait modulation system of claim 1, wherein the second stimulation signal produced by the stimulator is configured to promote dorsiflexion of a foot of the patient.

11. The gait modulation system of claim 1, wherein the processor is configured to determine based on the gait signal whether the patient is walking, standing or sitting.

12. The gait modulation system of claim 1, wherein the stimulation system is configured to produce the first stimulation signal for a pre-defined period of time.

13. The gait modulation system of claim 1, wherein the first threshold is calculated based on a dynamic range of the gait signal.

14. The gait modulation system of claim 1, wherein the second threshold is calculated based on a dynamic range of the gait signal.