Systems and apparatus for gait modulation and methods of use

• US 9,867,985 B2
• Filed: 03/24/2014
• Issued: 01/16/2018
• Est. Priority Date: 03/24/2014
• Status: Active Grant

• Current Assignee: Bioness Inc. (Smith & Nephew PLC)
• Original Assignee: Bioness Inc. (Smith & Nephew PLC)
• Inventors: Glukhovsky, Arkady, McBride, Keith
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/223,340
• Publication Number:
  US 20150265834A1
• Time in Patent Office: 1,394 Days
• Field of Search: 607 2, 607 49
• CPC Class Codes: A61B 5/1038 Measuring plantar pressure during gait
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/6807 Footwear
• CPC Class Codes: A61B 5/6811 External prosthesis
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61F 5/01 Orthopaedic devices, e.g. splints, casts or braces
• 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

Abstract

An apparatus includes a frame, a sensor, and an electric stimulator. The frame is removably couplable to a portion of a limb. The sensor is configured to produce a first signal associated with a gait characteristic at a first time, and a second signal associated with the gait characteristic at a second time, after the first time. The electric stimulator is removably coupled to the frame and is in electrical communication with an electrode assembly and the sensor to receive the first signal substantially at the first time and the second signal substantially at the second time. Based in part on the gait characteristic at the first time, the electric stimulator sends a third signal to the electrode assembly to provide an electric stimulation to a portion of a neuromuscular system of the limb substantially during a time period defined between the first time and the second time.

Claims

1. An apparatus, comprising:

a frame assembly configured to be removably coupled to a portion of a limb such that the portion of the limb is substantially enveloped by the frame;

a sensor coupled to the frame, the sensor including one of a tilt sensor, an accelerometer or a gyroscope, the sensor configured to produce a first signal and a second signal, the first signal associated with a gait characteristic at a first time, the second signal associated with the gait characteristic at a second time, after the first time, the first time and the second time defining a time period therebetween; and

an electric stimulator removably coupled to the frame assembly and in electrical communication with the sensor and an electrode assembly, the electrode assembly including a first set of electrodes configured to be in electrical communication with a first portion of a neuromuscular system of the limb, the electrode assembly including a second set of electrodes configured to be in electrical communication with a second portion of the neuromuscular system of the limb, the electric stimulator configured to receive the first signal from the sensor at the first time and the second signal from the sensor at the second time;

the electric stimulator configured to send a third signal to the electrode assembly at the first time, the third signal based at least in part on the first signal associated with the gait characteristic at the first time, the third signal operable to cause the first set of electrodes of the electrode assembly to provide an electrical stimulation having a first voltage to the first portion of the neuromuscular system of the limb resulting in dorsiflexion of a foot of the limb and to cause the second set of electrodes of the electrode assembly to provide an electrical stimulation having a second voltage, different from the first voltage, to the second portion of the neuromuscular system during the time period resulting in plantarflexion of the foot of the limb.

2. The apparatus of claim 1, wherein the gait characteristic is at least one of a tilt characteristic, an acceleration characteristic, or an angular characteristic.

3. The apparatus of claim 1, wherein the first signal at the first time is associated with a heel-off event and the second signal at the second time is associated with a heel-on event.

4. The apparatus of claim 1, wherein at least a portion of the electric stimulator is disposed in a housing and at least a portion of the sensor is disposed in the housing.

5. The apparatus of claim 1, wherein the sensor is a first sensor, the gait characteristic is a first gait characteristic, the first signal and the second signal being received by the electric stimulator via a first communication channel, the apparatus further comprising:

a second sensor physically distinct from the electric stimulator, the second sensor configured to produce a fourth signal and a fifth signal, the fourth signal associated with a second gait characteristic at the first time, the second signal associated with the second gait characteristic at the second time; and

the electric stimulator configured to receive the fourth signal from the second sensor substantially at the first time and the fifth signal from the second sensor substantially at the second time, the fourth signal and the fifth signal being received by the electric stimulator via a second communication channel, different from the first communication channel, the third signal sent from the electric stimulator based at least in part on the first gait characteristic and the second gait characteristic.

6. The apparatus of claim 5, wherein the second sensor is coupled to at least one of a shoe, a sock, a band, or an adhesive disposed about a foot of the limb.

7. The apparatus of claim 1, wherein the first signal and the second signal are received by the electric stimulator via a first communication channel, the electric stimulator is in wireless electrical communication with a control device via a second communication channel, different from the first communication channel, the control device configured to send a fourth signal to the electric stimulator, the fourth signal associated with one or more system parameters.

8. The apparatus of claim 1, wherein the electric stimulator is configured to electrically communicate via three communication channels.

9. The apparatus of claim 1, wherein the stimulator is configured to, based on at least one of the first signal or the second signal produced by the sensor, reduce the first voltage and increase the second voltage.

10. The apparatus of claim 1, wherein the electric stimulator is configured to electrically communicate via a plurality of communication channels, at least a first communication channel from the plurality of communication channels associated with a wired signal transmission, at least a second communication channel from the plurality of communication channels, different from the first communication channel, associated with a wireless signal transmission.

11. The apparatus of claim 1, wherein the sensor is at least partially included in the electric stimulator.

12. The apparatus of claim 1, wherein the limb is a first limb, the sensor is a first sensor, the communication channel is a first communication channel, the apparatus further comprising:

a second sensor physically distinct from the electrical stimulator and associated with a segment of a second limb, the second limb being contralateral to the first limb, the second sensor configured to produce a fourth signal,

the electric stimulator configured to receive the fourth signal from the second sensor via a second communication channel, different from the first communication channel.

21. The apparatus of claim 1, wherein the electric stimulator is configured to cause the electrical stimulation to the portion of the neuromuscular system of the limb to cease based at least in part on the second signal received from the sensor at the second time.

22. The apparatus of claim 1, wherein:

the electric stimulator is configured to send a fourth signal to the electrode assembly at the second time, the fourth signal based at least in part on the gait characteristic at the second time and operable to cause the electrode assembly to cease providing the electrical stimulation to the portion of the neuromuscular system of the limb resulting in dorsiflexion of the foot of the limb and to increase the second voltage of the electrical stimulation to the portion of the neuromuscular system of the limb resulting in plantarflexion of the foot of the limb.

13. An apparatus, comprising:

a frame assembly configured to be removably coupled to a portion of a first limb such that the portion of the first limb is substantially enveloped by the frame assembly;

an electric stimulator removably coupled to the frame assembly and in electrical communication with the electrode assembly, the electrode assembly configured to be in electrical communication with a portion of a neuromuscular system of the first limb; and

a sensor physically distinct from and in wireless electrical communication with the electric stimulator, the sensor being associated with a second limb contralateral to the first limb, the sensor configured to produce a first signal and a second signal, the first signal associated with a gait characteristic at a first time, the second signal associated with the gait characteristic at a second time, after the first time, the first time and the second time defining a time period therebetween;

the electric stimulator configured to receive the first signal from the sensor at the first time and the second signal from the sensor at the second time, the electric stimulator configured to send a third signal to the electrode assembly at the first time, the third signal based at least in part on the first signal and operable to cause the electrode assembly to provide an electrical stimulation to the portion of the neuromuscular system of the first limb during the time period resulting in at least one of dorsiflexion or plantarflexion of a foot of the first limb.

14. The apparatus of claim 13, wherein the sensor includes at least one of an accelerometer and a gyroscope.

15. The apparatus of claim 13, wherein the gait characteristic is at least one of an acceleration characteristic or a stabilization characteristic.

16. The apparatus of claim 13, wherein the electric stimulation during the time period transmitted to the portion of the neuromuscular system of the first limb has a first voltage during a first portion of the time period and a second voltage, less than the first voltage, during a second portion of the time period subsequent the first portion of the time period.

17. The apparatus of claim 13, wherein the first signal at the first time is associated with a heel-off event and the second signal at the second time is associated with a heel-on event.

18. The apparatus of claim 13, wherein the sensor is a first sensor, the gait characteristic is a first gait characteristic, the first signal and the second signal being received by the electric stimulator via a first wireless communication channel, the apparatus further comprising:

a second sensor coupled to the frame, the second sensor configured to produce a fourth signal and a fifth signal, the fourth signal associated with a second gait characteristic at the first time, the second signal associated with the second gait characteristic at the second time; and

the electric stimulator configured to receive the fourth signal from the second sensor at the first time and the fifth signal from the second sensor at the second time, the fourth signal and the fifth signal being received by the electric stimulator via one of a wired communication channel or a second wireless communication channel, different from the first wireless communication channel, the third signal sent from the electric stimulator based at least in part on the first gait characteristic and the second gait characteristic.

19. The apparatus of claim 13, wherein the electric stimulator is configured to electrically communicate via three communication channels.

20. The apparatus of claim 13, wherein the electric stimulator is a first electric stimulator, further comprising:

a second electric stimulator associated with the second limb and in electrical communication with the sensor.

23. An apparatus, comprising:

a frame assembly configured to be removably coupled to a portion of a limb such that the portion of the limb is substantially enveloped by the frame;

a first sensor coupled to the frame, the sensor including at least one of a tilt sensor, an accelerometer or a gyroscope, the first sensor configured to produce a first signal and a second signal, the first signal associated with a first gait characteristic at a first time, the second signal associated with the first gait characteristic at a second time, after the first time, the first time and the second time defining a time period therebetween;

a second sensor configured to produce a third signal and a fourth signal, the third signal associated with a second gait characteristic at the first time, the fourth signal associated with the second gait characteristic at the second time; and

an electric stimulator removably coupled to the frame assembly and in electrical communication with the first sensor, the second sensor and an electrode assembly, the second sensor being physically distinct from the electric stimulator, the electrode assembly configured to be in electrical communication with a portion of a neuromuscular system of the limb, the electric stimulator configured to receive, at the first time, the first signal from the first sensor and the third signal from the second sensor, the electric stimulator configured to receive, at the second time, the second signal from the first sensor and the fourth signal from the second sensor;

the electric stimulator configured to send a fifth signal to the electrode assembly at the first time, the fifth signal based at least in part on the first gait characteristic at the first time and the second gait characteristic at the first time, the fifth signal operable to cause the electrode assembly to provide an electrical stimulation to the portion of the neuromuscular system of the limb during the time period such that the electrical stimulation has a first voltage during a first portion of the time period and a second voltage, different than the first voltage, during a second portion of the time period subsequent the first portion of the time period.