Functional electrical stimulation systems

• US 8,788,049 B2
• Filed: 05/01/2007
• Issued: 07/22/2014
• 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): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US12/299,043
• Publication Number:
  US 20090069865A1
• Time in Patent Office: 2,639 Days
• Field of Search: 607 48- 49
• US Class Current: 607/48
• 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. An apparatus, comprising:

a sensor configured to produce a gait signal as a function of time, the gait signal associated with a force exerted by a lower limb of a patient; and

a processor configured to calculate a first threshold and a second threshold, the first threshold calculated based on a dynamic range of the gait signal, the first threshold associated with a first gait event, the second threshold calculated based on the dynamic range of the gait signal, the second threshold associated with a second gait event,

the processor configured to produce a first signal when the gait signal crosses the first threshold, the processor configured to produce a second signal when the gait signal crosses the second threshold.

2. The apparatus of claim 1, further comprising:

a wireless transmitter configured to transmit at least one of the first signal or the second signal to a stimulation system, the stimulation system configured to initiate an electronic stimulation when the first signal is received, the stimulation system configured to terminate the electronic stimulation when the second signal is received.

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

4. The apparatus of claim 1, wherein:

the gait signal includes a plurality of maximums and a plurality of minimums; and

the processor is configured to identify a first maximum from the plurality of maximums as being unrelated to ambulatory movement of the patient, the processor configured to calculate the dynamic range based on the plurality of maximums and the plurality of minimums, exclusive of the first maximum.

5. The apparatus of claim 4, wherein the first maximum occurs within a time period during which the patient is standing.

6. The apparatus of claim 1, wherein:

the gait signal includes a plurality of maximums and a plurality of minimums; and

the processor is configured to identify a first minimum from the plurality of minimums as being unrelated to ambulatory movement of the patient, the processor configured to calculate the dynamic range based on the plurality of maximums and the plurality of minimums, exclusive of the first minimum.

7. The apparatus of claim 6, wherein the first minimum occurs within a time period during which the patient is sitting.

8. The apparatus of claim 1, wherein:

the first gait event is a stance event; and

the second gait event is a swing event, the processor configured to produce a third signal after the first signal when the gait signal does not cross the second threshold within a predetermined time period.

9. An apparatus, comprising:

a sensor configured to produce a gait signal as a function of time, the gait signal associated with a force exerted by a lower limb of a patient; and

a processor configured to calculate, based on the gait signal, a first threshold and a second threshold, the first threshold associated with a first gait event, the second threshold associated with a second gait event,

the processor configured to produce a first signal when the gait signal crosses the first threshold at a first time, the processor configured to produce a second signal at a second time, the second time occurring a predetermined time period after the first time.

10. The apparatus of claim 9, wherein the processor is configured to calculate the predetermined time period based on the gait signal.

11. The apparatus of claim 9, wherein the processor is configured to produce the second signal at the second time when the gait signal fails to cross the second threshold within the predetermined time period after the first time.

12. The apparatus of claim 9, further comprising:

a wireless transmitter configured to transmit the first signal and the second signal to a stimulation system.

13. The apparatus of claim 9, wherein the processor is configured to detect the plurality of gait events, the plurality of gait events including a heel-on event and a subsequent heel-off event, the processor configured calculate the predetermined time period based on a time between the heel-on event and the heel-off event.

14. The apparatus of claim 9, wherein:

the first gait event is a heel-off event associated with a first time; and

the processor is configured calculate the predetermined time period based on a time between the heel-off event and a heel-on event associated with a second time earlier than the first time.

15. The apparatus of claim 9, wherein:

the first gait event is a heel-off event associated with a first time; and

the time period is greater than a time period between the heel-off event and a heel-on event associated with a second time earlier than the first time.

16. An apparatus, comprising:

a sensor configured to produce a gait signal as a function of time, the gait signal associated movement of a lower limb of a patient, the gait signal including a plurality of maximums and a plurality of minimums; and

a processor configured to calculate a dynamic range of the gait signal based at least in part on the plurality of maximums and the plurality of minimums, the processor configured to calculate, based on the dynamic range of the gait signal, a first threshold and a second threshold, the first threshold associated with a first gait event, the second threshold associated with a second gait event,

the processor configured to produce a first signal when the gait signal crosses the first threshold at a first time, the processor configured to produce a second signal when the gate signal crosses the second threshold within a predetermined time period after the first time, the processor configured to produce a third signal when the gate signal does not cross the second threshold within the predetermined time period after the first time.

17. The apparatus of claim 16, wherein the processor is configured to identify as invalid at least one of a maximum from the plurality of maximums or a minimum from the plurality of minimums.

18. The apparatus of claim 16, wherein the processor is configured to calculate the predetermined time period based on the gait signal.

19. The apparatus of claim 16, further comprising:

a housing configured to contain the sensor and the processor; and

a wireless transmitter disposed within the housing, the wireless transmitter configured to transmit the first signal and the second signal to a stimulation system.