FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS

• US 20090069865A1
• Filed: 05/01/2007
• Published: 03/12/2009
• Est. Priority Date: 05/01/2006
• Status: Active Grant

• Current Assignee: Bioness Neuromodulation Ltd.
• Original Assignee: Bioness Neuromodulation Ltd.
• Inventors: Dar, Amit, Rubin, Mark, Lasko, Eyal, Springer, Shmuel
• Granted Patent: US 8,788,049 B2
• Time in Patent Office: Days
• US Class Current: 607/49
• 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

1-20. -20. (canceled)

21. An apparatus, comprising:

a stimulator configured to receive a signal produced by a sensor via a communication pathway, the stimulator configured to produce a first stimulation signal in response to a signal received from the sensor via the communication pathway,

the stimulator configured to detect a failure of the communication pathway and produce a second stimulation signal when the failure is detected.

22. The apparatus of claim 21, wherein at least a portion of the communication pathway is a wireless communication pathway.

23. The apparatus of claim 21, wherein:

the signal produced by 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.

24. The apparatus of claim 21, wherein:

the signal produced by the sensor is a wireless signal; and

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

25. The apparatus of claim 21, wherein the second stimulation signal is different from the first stimulation signal.

26. The apparatus of claim 21, wherein:

the signal is a first signal from a plurality of signals produced by the sensor, the plurality of signals associated with a pattern of gait events; and

the stimulator is configured to produce the second stimulation signal at a predetermined time after the failure is detected, the predetermined time associated with the pattern of gait events.

27. The apparatus of claim 21, wherein the signal is a first signal from a plurality of signals produced by the sensor, the apparatus further comprising:

a sensor unit, the sensor unit including at least the sensor and a processor, the sensor unit configured to determine a plurality of heel-on events and a plurality of heel-off events based on the plurality of signals, the stimulation system configured to determine a stance time between a first heel-on event from the plurality of heel-on events and a subsequent first heel-off event from the plurality of heel-off events,

the stimulator configured to produce the second stimulation signal at a predetermined time after the failure is detected, the predetermined time associated with the stance time.

28. The apparatus of claim 21, wherein the stimulator is configured to verify the signal based on a unique identifier associated with the sensor.

29. An apparatus, comprising:

a gait sensor module configured to detect a first gait event from a plurality of gait events and produce a first signal when the first gait event is detected,

the gait sensor module configured calculate a time period within which a second gait event subsequent to the first gait event should be detected by the gait sensor module, the gait sensor module configured to produce a second signal when the second gait event is not detected by the gait sensor module within the time period.

30. The apparatus of claim 29, wherein the gait sensor module includes a wireless transmitter configured to transmit the first signal and the second signal to a stimulation system.

31. The apparatus of claim 29, wherein the gait sensor module 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 gait sensor module configured calculate the time period based on a time between the heel-on event and the heel-off event.

32. The apparatus of claim 29, wherein:

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

the gait sensor module is configured calculate the 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.

33. The apparatus of claim 29, 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.

34. The apparatus of claim 29, wherein the second signal is different from the first signal.

35. The apparatus of claim 29, wherein the gait sensor module includes:

a force sensor configured to produce a force signal associated with a force exerted by a portion of a foot as a function of time; and

a processor configured to detect the first gait event when the magnitude of the force signal crosses a predetermined threshold.

36. 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.

37. The apparatus of claim 36, further comprising:

a wireless transmitter configured to transmit either one of the first signal and 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.

38. The apparatus of claim 36, wherein the processor is configured to determine based on the gait signal whether the patient is walking, standing or sitting.

39. The apparatus of claim 36, 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.

40. The apparatus of claim 39, wherein the first maximum occurs within a time period during which the patient is standing.

41. The apparatus of claim 36, 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.

42. The apparatus of claim 41, wherein the first minimum occurs within a time period during which the patient is sitting.

43. An apparatus, comprising:

a sensor module configured to produce at least one of a gait signal and a validation signal, the gait signal associated with a gait event of a patient; and

a stimulation system configured to be in electronic communication with the sensor module, the stimulation system configured to produce a first stimulation signal in response to the gait signal, the stimulation system configured to produce a second stimulation signal when neither the gait signal nor the validation signal is received within a predetermined time period.

44. The apparatus of claim 43, wherein the stimulation system is configured to be in wireless electronic communication with the sensor module.

45. The apparatus of claim 43, wherein the second stimulation signal is different from the first stimulation signal.

46. The apparatus of claim 43, wherein:

the gait signal is a first gait signal from a plurality of gait signals produced by the sensor module; and

the sensor module is configured to calculate the predetermined time based on the plurality of gait signals.