# US 8,788,049 B2 · Functional electrical stimulation systems

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- Number: US 8,788,049 B2
- Document ID: US8788049B2
- Status: Granted
- Kind: B2
- Application number: 12/299,043
- Filed: 2007-05-01
- Published: 2009-03-12
- Granted: 2014-07-22
- Earliest claimed: 2006-05-01
- Assignees: Bioness Neuromodulation Ltd.
- Applicants: Eyal Lasko; Shmuel Springer; Mark Rubin; Amit Dar
- Inventors: Eyal Lasko; Shmuel Springer; Mark Rubin; Amit Dar
- Web page: https://patentgrep.com/patent/US8788049B2

## CPC

- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61B 5/1038: {Measuring plantar pressure during gait}
- A61H 3/00: Appliances for aiding patients or disabled persons to walk about (apparatus for helping babies to walk A47D13/04 {; applying electrical currents by contact electrodes for stimulating motor muscles, e.g. walking assistance A61N1/36003})
- A61N 1/0452: {Specially adapted for transcutaneous muscle stimulation [TMS]}
- A61N 1/0484: {Garment electrodes worn by the patient}
- A61N 1/36031: {using physiological parameters for adjustment}
- 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
- H03K 17/9625: {using a force resistance transducer}
- H01H 3/14: adapted for operation by a part of the human body other than the hand, e.g. by foot
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)
- G01L: MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE (weighing G01G)
- H03K: PULSE TECHNIQUE (measuring pulse characteristics G01R; modulating sinusoidal oscillations with pulses H03C; transmission of digital information H04L; discriminator circuits detecting phase difference between two signals by counting or integrating cycles of oscillation H03D3/04; automatic control, starting, synchronisation or stabilisation of generators of electronic oscillations or pulses where the type of generator is irrelevant or unspecified H03L; coding, decoding or code conversion, in general H03M)
- H01H: ELECTRIC SWITCHES; RELAYS; SELECTORS; EMERGENCY PROTECTIVE DEVICES (contact cables H01B7/10; electrolytic self-interrupters H01G9/18; emergency protective circuit arrangements H02H; switching by electronic means without contact-making H03K17/00)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 4)

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

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

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

### Claim 8 (depends on 1)

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.

### Claim 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.

### Claim 10 (depends on 9)

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

### Claim 11 (depends on 9)

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.

### Claim 12 (depends on 9)

The apparatus of claim 9, further comprising:
a wireless transmitter configured to transmit the first signal and the second signal to a stimulation system.

### Claim 13 (depends on 9)

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.

### Claim 14 (depends on 9)

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.

### Claim 15 (depends on 9)

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.

### Claim 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.

### Claim 17 (depends on 16)

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.

### Claim 18 (depends on 16)

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

### Claim 19 (depends on 16)

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.
