WO-2026096408-A1 - ELECTRONIC TISSUE SENSING AND STIMULATION SYSTEM AND METHOD

Abstract

A system, method, and wearable device configured to both actuate a muscle and to sense the muscle's response to the actuation to determine treatment parameters for a subsequent actuation. The actuation and sensing components are in communication with a machine learning component to evaluate the data output from the sensing and actuation and to determine whether and how to adjust treatment parameters for subsequent treatment sessions.

Inventors

• GERSHANOK, Samuel A.
• COHEN-KARNI, Itzhaq

Assignees

• CARNEGIE MELLON UNIVERISTY

Dates

Publication Date

20260507

Application Date

20251028

Priority Date

20241028

Claims (20)

1. 1. A system for treating muscular degeneration, comprising: an actuation subsystem configured to stimulate at least one muscle during a treatment and to generate actuation output data; a sensing subsystem configured to communicate with the actuation subsystem and to evaluate the actuation output data to identify at least one physiological response by the stimulated muscle and to generate sensing output data based upon the evaluation; and at least one machine learning subsystem in communication with the actuation subsystem and the sensing subsystem, the at least one machine learning subsystem configured to process the sensing output data to generate at least one treatment parameter.
2. 2. The system of Claim 1, wherein the machine learning subsystem archives the sensing output data from a first treatment for comparison to a sensing output data from a subsequent treatment.
3. 3. The system of Claim 1, wherein the at least one treatment parameter is communicated to the actuation subsystem for use during a subsequent treatment.
4. 4. The system of Claim 1, wherein the actuation subsystem comprises at least one stimulation method selected from the group consisting of electrical, mechanical, bioelectrical, sound, and heat.
5. 5. The system of Claim 1, wherein the sensing subsystem is configured to incorporate at least one sensing modality selected from the group consisting of electrophysiological, mechanical, optical, thermal, and pressure and wherein the at least one modality can quantify a neuromuscular state or a therapeutic response.
6. 6. The system of Claim 1 , wherein the actuation subsystem and the sensing subsystem are configured to fit on a wearable device. 279430.357_NP
7. 7. The system of Claim 1, also comprising an array of sensors configured to function as part of the actuation subsystem and the sensing subsystem.
8. 8. A wearable device for treating muscular degeneration, comprising: an actuation subsystem configured to actuate at least one muscle and configured to generate actuation output data; a sensing subsystem configured to receive the actuation output data and configured to identify at least one physiological response by the actuated muscle based upon the actuation output data and to generate sensing output data; and at least one machine learning subsystem in communication with the actuation subsystem and the sensing subsystem, the at least one machine learning subsystem configured to process the sensing output data to generate at least one treatment parameter.
9. 9. The device of Claim 8, wherein the actuation subsystem, the sensing subsystem, and the at least one machine learning subsystem are incorporated into a wearable cuff configured to wrap around a body part.
10. 10. The device of Claim 8, wherein the cuff comprises: a skin interface layer that contacts the body part; a sensing and electrode layer configured with at least one electrode that is integrated into a flexible substrate; an electronics pod configured to run the machine learning subsystem and to provide communication and energy to the actuation subsystem, the sensing subsystem, and the machine learning subsystem; a conductive pathway layer comprising conductive fibers or printed metallic traces forming flexible circuits connecting the electrodes to the electronics pod; an insulating and structural layer that isolates the conductive fibers or metallic traces from an environment around the cuff; and 279430.357_NP an outer shell.
11. 11. The device of Claim 9 also comprising an array of electrodes configured to contact the body part.
12. 12. The device of Claim 11 , wherein the electrodes are configured for actuation and sensing.
13. 13. The device of Claim 10, further comprising a display on the outer shell configured to display instructions to a user.
14. 14. The device of Claim 8, wherein the machine learning subsystem is configured as a continuous, closed loop to process real-time data from the sensing subsystem to provide the at least one treatment parameter.
15. 15. The device of Claim 8, wherein sensing subsystem is electrically and mechanically coupled to the actuation subsystem to ensure temporal alignment of stimulation and sensing.
16. 16. A method of treating muscular degeneration, comprising: evaluating a muscle’s physiology with a sensing subsystem to produce sensing output data; processing sensing output data by a machine learning subsystem to produce at least one treatment parameter; actuating the muscle with an actuation subsystem according to the at least one treatment parameter; and repeating the evaluating and processing steps to produce at least one updated treatment parameter.
17. 17. The method of Claim 16, also comprising verifying a proper placement of at least one electrode on a body part prior to evaluating a muscle’s physiology.
18. 18. The method of Claim 16, wherein the machine learning subsystem comprises: extracting features from and preprocessing the sensing output data to filter out noise and artifacts from the sensing output data to generate filtered output data; and 279430.357_NP processing the filtered output data for model prediction and adaptive control to produce the at least on treatment parameter for use by the actuation subsystem.
19. 19. The method of Claim 16, wherein the steps are repeated until the sensing subsystem detects no continued muscular degeneration from the muscle’s physiology.
20. 20. A device for treating muscular degeneration comprising: an actuation subsystem configured to stimulate at least one muscle during a treatment and to generate actuation output data; and a sensing subsystem configured to communicate with the actuation subsystem and configured to receive the actuation output data, and evaluate the actuation output data to determine at least one physiological attribute of the muscle, wherein the actuation subsystem and the sensing subsystem are configured as a portable system.

Description

279430.357_NP TITLE ELECTRONIC TISSUE SENSING AND STIMULATION SYSTEM AND METHOD CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority to U.S. Provisional Application Serial No. 63/712,741, filed on October 28, 2024, which application is incorporated by reference herein in its entirety. STATEMENT REGARDING FEDERAL SPONSORSHIP [0002] This invention was made with the support of the United States government under the Department of the Interior for DARPA D20AC00002. The U.S. government has certain rights in the invention. BACKGROUND OF THE INVENTION Field of the Invention [0003] The present invention relates to electrical, mechanical, and acoustic tissue sensing and stimulation to counteract muscle degeneration. Background of the Invention [0004] The present invention was inspired by treatment needs relating to volumetric muscle loss (“VML”), a traumatic or surgical injury that results in the irreversible loss of skeletal muscle tissue beyond the body’s natural capacity for regeneration, leading to chronic weakness, fibrosis, and functional impairment. Muscular degeneration, and corresponding treatment needs, also exist with other injuries and conditions as explained herein. [0005] Muscular degeneration, a broad term for VML, muscle atrophy, muscle wasting, and neuromuscular degeneration (collectively herein “muscular degeneration”), describes the progressive loss of skeletal muscle mass, strength, and function. These conditions can result from a wide range of causes and have significant implications for mobility, independence, and overall health on individuals suffering from them. 279430.357_NP [0006] Some examples of muscular degeneration include the following: (i) disuse atrophy, which can be caused by physical inactivity or immobilization and is often reversible with exercise and physical therapy; (ii) neurogenic atrophy, which results from nerve damage or neurological diseases like Amyotrophic Lateral Sclerosis (“ALS”), Spinal Muscular Atrophy (“SMA”), and Multiple Sclerosis (“MS”); pathological atrophy (e.g., Cachexia), which is characterized by weight loss, muscle wasting, loss of appetite, and weakness; (iii) muscular dystrophies (e.g., Duchenne, Becker, Limb-Girdle) that cause progressive muscle degeneration and weakness; (iv) sarcopenia, which is age-related loss of muscle mass; and (v) post-surgical function muscle loss after a wide-variety of surgeries, such as total knee arthroplasty (“TKA”); anterior cruciate ligament (“ACL”) reconstruction; meniscus repair or arthroscopy; total hip arthroplasty (“THA”); rotator cuff repair; spinal fusion or laminectomy; fracture fixation (e.g., femur, tibia, humerus); amputation; shoulder arthroplasty (TSA or RS A); Achilles Tendon repair; anterior cervical discectomy and fusion (“ACDF”); lumbar discectomy; shoulder labral repair (Bankart or SLAP); total ankle arthroplasty or fusion; and carpal tunnel or peripheral nerve decompression. Whether because the muscle itself is unable to be exercised or moved normally for a period of time due to injury or illness to the specific muscle(s) or because the specific muscle(s) cannot be moved or worked because of an injury or illness to an adjacent muscle, the lack of movement and use of any muscle in the body eventually leads to muscular degeneration. Clinically, muscle wasting conditions manifest the following symptoms: progressive muscle weakness and shrinking, fatigue, low endurance, difficulty with mobility, facial or limb weakness, trouble swallowing or speaking (in neurogenic causes), weight loss, postural changes and muscle tone reduction. [0007] In general, the treatment for muscular degeneration depends on the underlying cause but treatments may include any or a combination of the following: physical therapy, exercise, resistance training to rebuild muscle mass, mobility aids, rehabilitation, nutritional 279430.357_NP support (high-protein, high-calorie diets), supplements (e.g., vitamin D, B12, creatine), pharmacologic interventions e.g. anti-inflammatory agents, anabolic steroids, or experimental drugs), disease-specific treatments (e.g., riluzole for ALS, corticosteroids for Duchenne MD), and management of the underlying disease or illness. The general practice is to begin treatment for muscular degeneration after the muscle loss becomes visible to the clinician’s eye or several weeks after the injury or illness has been diagnosed, which is when physical therapy normally would begin. This results in a delay between when muscular degeneration may have begun at a cellular level and when it is noticed and treated according to standard medical protocol. [0008] Physical therapists use a broad range of rehabilitation techniques to combat muscular degeneration conditions, aiming to preserve or restore muscle mass, strength, and mobility. Traditional exercise-based interventions, such as progressive resistance training, eccentric and isometric exercises, and task-oriented movement retraining