IP Library › Granted Patent US 12,377,266
Granted Patent B2
US 12,377,266 · App. 18/142,837 · Granted Aug 5, 2025

Systems and apparatus for gait modulation and methods of use

Inventors: Arkady Glukhovsky (Valencia, CA); Keith McBride (Ventura, CA)
Assignee: Bioness Medical Inc.
A61N1/36003A61B5/112A61B5/4836A61B5/4851A61B5/6811A61B5/1038A61B5/6807A61B5/6828A61F5/01A61N1/0452A61N1/0484
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Quick Facts
Patent No.
US 12,377,266
App. No.
18/142,837
Granted
Aug 5, 2025
Kind
B2
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 (41)

1. A method, comprising:

receiving, at an electric stimulator and from a sensor, a first signal associated with a gait characteristic;

calculating, via a processor operatively coupled to the electric stimulator, one or more system parameters based at least in part on the first signal associated with the gait characteristic;

sending a first stimulation signal, based at least in part on the one or more system parameters, from the electric stimulator to an electrode assembly to cause the electrode assembly to provide an electric stimulation to a portion of a neuromuscular system of a limb resulting in one of dorsiflexion or plantarflexion of a foot of the limb;

receiving, at the electric stimulator and from the sensor, a second signal associated with the gait characteristic; and

terminating or decreasing the electric stimulation of the portion of the neuromuscular system of the limb based on the receiving of the second signal associated with the gait characteristic, the terminating or decreasing resulting in a ceasing or relaxation of the one of the dorsiflexion or the plantarflexion; and

sending a second stimulation signal from the electric stimulator to the electrode assembly to cause the electrode assembly to provide the electric stimulation to a different portion of the neuromuscular system of the limb resulting in the other of the dorsiflexion or the plantarflexion of the foot of the limb substantially concurrently with or in a substantially inverse process to the ceasing or relaxation of the one of the dorsiflexion or the plantarflexion resulting from the terminating or the decreasing.

2. The method of claim 1 , wherein the sensor is at least partially integrated with the electric stimulator.

3. The method of claim 1 , wherein the electric stimulator is in wireless electrical communication with a control device, the calculating one or more system parameters includes calculating one or more system parameters defined by the control device.

4. The method of claim 1 , wherein the receiving of the first signal associated with the gait characteristic is via a wireless communication mode; and

the receiving of the second signal associated with the gait characteristic is via the wireless communication mode.

5. The method of claim 1 , wherein the sending the first stimulation signal from the electric stimulator to the electrode assembly to cause the electrode assembly to provide an electric stimulation to the portion of the neuromuscular system of the limb is associated with one of a heel-off event or a heel-on event during ambulatory motion of the limb; and

the terminating or decreasing the electric stimulation of the portion of the neuromuscular system of the limb is associated with the other of the heel-on event or the heel-off event during the ambulatory motion of the limb.

6. The method of claim 1 , wherein:

the terminating or decreasing includes decreasing a voltage of the electric stimulation to the portion of the neuromuscular system of the limb, and

the sending the second stimulation signal includes increasing a voltage of the electric stimulation to the different portion of the neuromuscular system of the limb.

7. The method of claim 1 , wherein the terminating or decreasing includes decreasing a voltage associated with the electric stimulation provided to the portion of the neuromuscular system of the limb in an inversely proportional process to increasing a voltage associated with the electric stimulation provided to the different portion of the neuromuscular system of the limb.

8. An apparatus, comprising:

a frame 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 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 and in electrical communication with the sensor, an electrode assembly, and a processor, 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 processor configured to calculate a system parameter based at least in part on information stored in a memory and the first signal, the memory being operatively coupled to the processor and the electric stimulator,

the electric stimulator configured to send a third signal to the electrode assembly, the third signal based at least in part on the system parameter calculated by the processor, the third signal operable to cause a first portion of the electrode assembly to provide an electrical stimulation to the first portion of the neuromuscular system of the limb resulting in dorsiflexion of a foot of the limb, the electric stimulator configured to send a fourth signal to the electrode assembly at least one of substantially concurrently with or substantially inversely proportional to a termination or modulation of the third signal resulting in a relaxation of dorsiflexion, the fourth signal based at least in part on the second signal and operable to cause a second portion of the electrode assembly to provide an electrical stimulation to the second portion of the neuromuscular system of the limb resulting in plantarflexion of the foot of the limb.

9. The apparatus of claim 8 , wherein the sensor includes at least one of a tilt sensor, an accelerometer or a gyroscope.

10. The apparatus of claim 8 , 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.

11. The apparatus of claim 8 , wherein:

the third signal is operable to cause the first set of electrodes of the electrode assembly to provide the electrical stimulation having a first voltage,

the fourth signal is operable to cause the second set of electrodes of the electrode assembly to provide the electrical stimulation having a second voltage, different from the first voltage.

12. The apparatus of claim 11 , wherein the electric 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.

13. The apparatus of claim 11 , wherein the electric stimulator is configured to decrease the first voltage and to increase the second voltage at least one of substantially concurrently with or substantially inversely proportional to the decrease in the first voltage.

14. The apparatus of claim 8 , 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.

15. The apparatus of claim 8 , wherein the electric stimulator is configured to cause the electrical stimulation to the first 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.

16. The apparatus of claim 8 , wherein the electric stimulator is configured to cause the electrical stimulation to the first portion of the neuromuscular system of the limb to cease substantially concurrently with sending the fourth signal to the electrode assembly.

17. The apparatus of claim 8 , wherein the sensor is a first sensor coupled to the frame, the apparatus further comprising:

a second sensor configured to produce a fifth signal and a sixth signal, the fifth signal associated with a second gait characteristic at the first time, the sixth signal associated with the second gait characteristic at the second time,

the electric stimulator in electrical communication with the second sensor, the second sensor being physically distinct from the electric stimulator,

the electric stimulator configured to receive the fifth signal from the second sensor, the electric stimulator configured to receive the sixth signal from the second sensor;

the processor configured to calculate the system parameter based at least in part on information stored in the memory, the first signal, and the fifth signal.

18. The apparatus of claim 17 , wherein the third signal is operable to cause the electrode assembly to provide the electrical stimulation to the first portion of the neuromuscular system of the limb 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.

19. The apparatus of claim 8 , 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.

20. The apparatus of claim 8 , wherein the gait characteristic is at least one of a tilt characteristic, an acceleration characteristic, or an angular characteristic.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 21, 2025
From: BIONESS INC.; BIOVENTUS COOPERATIEF, U.A.; BIOVENTUS LLC
To: BIONESS MEDICAL, INC.
Reel/Frame 070581/0431 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2023
From: GLUKHOVSKY, ARKADY; MCBRIDE, KEITH
To: BIONESS INC.
Reel/Frame 063540/0580 →
Continuity (5)
Continuation 17103249 · Nov 24, 2020
Continuation 16146368 · Sep 28, 2018
Continuation 15872634 · Jan 16, 2018
Division 14223340 · Mar 24, 2014
Related Publication 20240033511A1 · Feb 1, 2024
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