# US 2024/0197237 A1 · Systems, devices, and method for the treatment of osteoarthritis

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- Number: US 2024/0197237 A1
- Document ID: US20240197237A1
- Status: Published application
- Kind: A1
- Application number: 18/231,049
- Filed: 2023-08-07
- Published: 2024-06-20
- Earliest claimed: 2015-07-31
- Assignees: Cala Health, Inc.
- Applicants: Cala Health, Inc.
- Inventors: Samuel Richard Hamner; Kathryn H. Rosenbluth; Scott Lee Delp; Daniel Lev Coleman; Peter Bradley Shull; Serena HanYing Wong
- Web page: https://patentgrep.com/patent/US20240197237A1

## CPC

- A61B 5/395: Details of stimulation, e.g. nerve stimulation to elicit EMG response
- A43B 3/34: with electrical or electronic arrangements
- A43B 7/141: {having an anatomical or curved form}
- A61B 5/112: {Gait analysis}
- A61B 5/1121: {Determining geometric values, e.g. centre of rotation or angular range of movement}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/486: {Biofeedback (using electroencephalography [EEG] A61B5/375)}
- A61B 5/6829: {Foot or ankle}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/0484: {Garment electrodes worn by the patient}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61N 1/36021: {for treatment of pain}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/36034: {specified by the stimulation parameters}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/1038: {Measuring plantar pressure during gait}
- A61B 5/6807: {Footwear}
- A61B 5/6828: {Leg}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A43B: CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
- 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)

## Abstract

The present disclosure describes devices, methods and systems for modifying or altering gait kinematics via sensory augmentation and/or modifying muscle activation patterns via augmented motor learning to slow the progression of and/or reduce the pain associated with knee OA, particularly during gait (e.g., walking, running, stair climbing, etc.). Sensors can be used to measure gait parameters and characteristics and muscle activation patterns. Stimulation can be provided to the individual in order to promote learning new gait kinematics and muscle activation patterns.

## Claims

### Claim 1

(canceled)

### Claim 2

A system for reducing knee pain associated with osteoarthritis in an individual, the system comprising:
a wearable sensor for measuring a gait parameter; and
a therapy device in communication with the wearable sensor, the therapy device configured to deliver a sensory stimulation based on the measured gait parameter that is configured to alter the individual's gait, wherein the sensory stimulation has a stimulation parameter that is proportional to a deviation of the measured gait parameter from a set range or value for the gait parameter;
wherein the sensory stimulation is configured to reduce an excitability of a gastrocnemius muscle and enhance an excitability of a soleus muscle.

### Claim 3 (depends on 2)

The system of claim 2, wherein the sensory stimulation is electrical and is configured to not induce contraction of a muscle.

### Claim 4 (depends on 2)

The system of claim 2, wherein the sensory stimulation is configured to enhance motor plasticity.

### Claim 5 (depends on 2)

The system of claim 2, wherein the sensory stimulation is tactile or auditory.

### Claim 6 (depends on 2)

The system of claim 2, wherein the sensory stimulation is configured to be provided in a fading feedback manner.

### Claim 7 (depends on 2)

The system of claim 2, wherein the wearable sensor comprises an IMU or a force sensor.

### Claim 8 (depends on 2)

The system of claim 2, wherein the gait parameter is foot progression angle, toe angle, ankle plantar flexion angle, step width, knee flexion angle, knee adduction angle, or knee adduction moment, knee flexion moment, or ankle plantar flexion moment, or any combination of these gait parameters.

### Claim 9 (depends on 2)

The system of claim 2, wherein the wearable sensor and/or therapy device comprises a knee band, ankle band, leg band, sock, knee brace, ankle brace, shoe, insole, compliant patch, pants, leg sleeve, knee sleeve, ankle sleeve, knee wrap, foot wrap, ankle wrap, or shoe attachment.

### Claim 10

A system for reducing knee pain associated with osteoarthritis in an individual, the system comprising:
a first wearable EMG sensor configured for measuring an activation of a gastrocnemius muscle;
a second wearable EMG sensor configured for measuring an activation of a soleus muscle; and
a therapy device in communication with the first and second wearable EMG sensors, the therapy device configured to deliver sensory stimulations based on the measured activation of the gastrocnemius muscle and the soleus muscle, wherein the sensory stimulations are configured to provide feedback to reduce the activation of the gastrocnemius muscle and enhance the activation of the soleus muscle.

### Claim 11 (depends on 10)

The system of claim 10, further comprising a wearable sensor for measuring a gait event.

### Claim 12 (depends on 11)

The system of claim 11, wherein the gait event is selected from the group consisting of foot strike and toe off.

### Claim 13 (depends on 11)

The system of claim 11, wherein the therapy device is configured to deliver the stimulations based on the measured activation.

### Claim 14 (depends on 11)

The system of claim 11, wherein the therapy device is configured to deliver the stimulation configured to enhance the activation of the soleus muscle based on the measured activation.

### Claim 15

A system for reducing knee pain associated with osteoarthritis in an individual, the system comprising:
a wearable sensor for measuring a gait parameter;
a wearable EMG sensor for measuring an activation of a gastrocnemius muscle; and
a therapy device in communication with the wearable sensor and the wearable EMG sensor, the therapy device configured to deliver a first sensory stimulation based on the measured gait parameter that is configured to alter the individual's gait and a second sensory stimulation based on the measured activation of the gastrocnemius muscle, wherein the first sensory stimulation has a stimulation parameter that is proportional to a deviation of the measured gait parameter from a set range or value for the gait parameter, wherein the second sensory stimulation is configured to inform the individual to reduce the activation of the gastrocnemius muscle.

### Claim 16 (depends on 15)

The system of claim 15, wherein the therapy device is configured to deliver a fourth stimulation configured to enhance the activation of a soleus muscle.

### Claim 17

A system for reducing knee pain associated with osteoarthritis in an individual, the system comprising:
a wearable sensor for measuring a gait parameter;
a wearable EMG sensor for measuring an activation of a soleus muscle; and
a therapy device in communication with the wearable sensor and the wearable EMG sensor, the therapy device configured to deliver a first sensory stimulation based on the measured gait parameter that is configured to alter the individual's gait and a second sensory stimulation based on the measured activation of the soleus muscle, wherein the first sensory stimulation has a stimulation parameter that is proportional to a deviation of the measured gait parameter from a set range or value for the gait parameter, wherein the second sensory stimulation is configured to inform the individual to increase activation of the soleus muscle.

### Claim 18 (depends on 17)

The system of claim 17, wherein the therapy device is configured to deliver a third stimulation configured to enhance the activation of the soleus muscle.

### Claim 19 (depends on 18)

The system of claim 18, wherein the therapy device is configured to deliver a fourth stimulation configured to reduce activation of a gastrocnemius muscle.
