US-12623068-B1 - Wearable neurostimulation system and method with curated therapy

US12623068B1US 12623068 B1US12623068 B1US 12623068B1US-12623068-B1

Abstract

Systems and methods for providing curated neurostimulation are disclosed such that users are enabled to provide improved therapy in a home environment. Stimulation protocols can be assessed to provide improved targeted stimulation of a nerve and less unwanted side effects. Sets of stimulation montages and associated weights are defined and are selected or adjusted in pre-defined using pre-defined operations that simplify adjustment of characteristics of the stimulation field such as the geometry and location of the provided stimulation. Stimulation matrix pads are arranged and activated to provide advantages. Strategies for adjusting the intensity of the stimulation field incorporate weighting values in non-primary channels and are disclosed. Curated neurostimulation can also include providing defined schedules for events and activities related to the therapy such as providing schedules for stimulation treatment, surveying a user, providing education and remote user support.

Inventors

Michael Sasha John
Brian Hoffer
RACHEL LICHTE
JON LAWSON
Mike Labbe
Keith R. Carlton
Paul B. Yoo
Suranjan Roychowdhury
Tamara Baynham
KEN W. MARIASH
David Lubensky
John Lai

Assignees

EBT MEDICAL, INC.

Dates

Publication Date: 20260512
Application Date: 20230119

Claims (15)

1 . A Neurostimulation system for stimulating a nerve of a person using a library of weighting functions, the system comprising: (a) a neurostimulator configured to programmably provide stimulation signals to a set of stimulation pads of a stimulation matrix; (b) a stimulation matrix having a set of stimulation pads which include at least 4 stimulation pads arranged in a defined geometric pattern on a flexible backing using an electrically non-conductive substrate, the stimulation matrix positioned external to a person and to provide a selected geometric pattern of electrical stimulation to a skin surface of the person; and, (c) a stimulation program within a processor configured to provide stimulation waveforms to each stimulation pad of the set of stimulation pads said waveforms being adjusted in intensity according to a library of weighting values for a set of stimulation montages, with each stimulation montage of the set of stimulation montages having weighting values defined for each stimulation pad of the set of stimulation pads to adjust an intensity of the stimulation waveforms provided to each stimulation pad, said weighting values selected using a set of criteria, wherein said library of weighting values is selected from the group of: defining a set of stimulation montages for permitting a user to selectively displace a stimulation field while decreasing perceptual risks to said person; and, defining a set of stimulation montages to be used during stimulation treatment.
2 . The neurostimulation system of claim 1 wherein the set of stimulation montages have weighting values that are defined according to a feature that provides a benefit that successful recruitment of a saphenous nerve of a user is obtained in a user friendly and uncomplicated manner.
3 . The neurostimulation system of claim 2 , wherein the feature is realized by a software program that asks a user to confirm that paresthesia is occurring.
4 . The neurostimulation system of claim 2 , wherein the feature is realized by a software program that asks a user to confirm the most distal region where paresthesia is occurring.
5 . The neurostimulation system of claim 1 wherein the set of stimulation montages have weighting values that are defined according to the feature to provide improved adjustment of amplitude levels and waveforms used during a stimulation treatment.
6 . The neurostimulation system of claim 1 , wherein the stimulation program is further configured with a feature that is realized by a software program that reminds a user to increase stimulation amplitude a selected number of minutes after the beginning of the treatment.
7 . The neurostimulation system of claim 1 , wherein a field location display is provided which graphically displays information about a selected stimulation montage to reinforce the user's perception of the adjustment of the stimulation field.
8 . The neurostimulation system of claim 7 , wherein the field location display is provided on the neurostimulation device.
9 . The neurostimulation system of claim 7 , wherein the field location display is provided on a user device that communicates with the neurostimulator.
10 . The neurostimulation system of claim 1 , further including a field steering manager interface that includes “advanced” controls for adjusting at least one of the group of: a) characteristics of the stimulation field such as the horizontal or vertical center of the field; b) the number of montages that are used to move the field from a first to a second location; and, c) parameter values related to the spread and fall-off of the field and combinations thereof.
11 . The neurostimulation system of claim 1 , further including a program that adjusts a set of weighting values for at least one stimulation montage of the set of stimulation montages based upon the amplitude used at a primary channel.
12 . The neurostimulation system of claim 11 , wherein the set of weighting values are adjusted so that a fall-off in weighting values are larger when the amplitude of the primary channel stimulation signals is above nerve recruitment threshold.
13 . The neurostimulation system of claim 1 , wherein the number of stimulation montages used when providing subsequent stimulation therapy is based upon the results of an assessment procedure of the person.
14 . The neurostimulation system of claim 1 , wherein the control of the location of the stimulation field is determined by a control that is a slider.
15 . The neurostimulation system of claim 1 , wherein the control of the location of the stimulation field is determined by a control that is a set of buttons corresponding to columns of a stimulation matrix.

Description

REFERENCE TO RELATED APPLICATIONS This Application is a continuation in part of U.S. patent Ser. No. 17/305,792 filed Jul. 14, 2021 which is based upon Provisional Application Ser. No. 63/052,192 filed on Jul. 15, 2020. INCORPORATION BY REFERENCE This Application incorporates by reference patent application Ser. No. 17/305,792 filed Jul. 14, 2021 and Provisional Application Ser. No. 63/052,192 filed at the United States Patent & Trademark Office on Jul. 15, 2020. FIELD OF THE INVENTION The invention relates to the field of stimulating biological tissue to improve the health or wellness of a user. BACKGROUND Stimulation of biological tissue can be used to improve health and wellness. Stimulation of peripheral tissue may cause changes at both peripheral and central nervous system sites in the treatment of disease or for the promotion of wellness by modulating the function of organs. Stimulation of the vagus nerve(s) is a good example of stimulation at a peripheral nerve site in the neck that modulates brain and heart activity and produce systemic changes in immune and metabolic activity. Stimulation of cranial nerves can provide relatively non-invasive treatment options for conditions such as headache or migraine rather than requiring direct stimulation of brain tissue. Bioelectronic medicine is progressively drawing increased focus as a non-pharmaceutical treatment option for various diseases. Stimulation of peripheral nerve targets to treat unwanted symptoms, medical disorders, and conditions, or to promote health or create desired changes (e.g., normalization of activity, decreases in abnormal activity, or decrease in severity of unwanted symptoms) in the brain or body, is attractive since this can provide benefit without the risks and invasiveness of direct stimulation of organs such as the brain or heart. Target stimulation sites in limb areas such as nerves in the arms, hands, legs and feet have been shown to provide benefit in treating, or improving symptoms of, a wide array of disorders. Candidate sites can be stimulated, and stimulation parameters and treatment schedules can be assessed for medical benefit in an individual or population of individuals who have been diagnosed (or “self-diagnosed”) with a medical condition. Unwanted symptoms or states related to, for example, the following: pelvic floor disorders; hypertension; digestive or gastrointestinal disorders; pain; immunological or metabolic disorders or states, obesity; attentional, psychiatric or cognitive disorders; movement disorders; restless leg syndrome; addiction or substance abuse; appetite; and other disorders, symptoms, or states which may be typically treated with medication can be treated with electrical stimulation which provides less risks of side-effects or drug interactions. Stimulation of nerves of the leg, arm, or neck may offer sites for a wide treatment of common disorders including cardiovascular disorders such as hypertension. Stimulation of peripheral nerves can modulate and “re-balance” the sympathetic and parasympathetic nervous system, and provide therapy to the autonomic nervous system and homeostatic functions. Stimulation of nerves in the lower leg offer opportunities to treat disorders such as pelvic floor disorders such as those that include urinary and fecal incontinence which may manifest with pathology related to urge (e.g., overactive bladder or “OAB”). The inventors have shown that saphenous nerve (SAFN) stimulation for treatment of OAB symptoms has many benefits compared to other candidate peripheral neuromodulation targets (e.g., preferred sensation of stimulation, less affected by comorbidities such as edema, stronger/more pervasive treatment response, and less risks). When stimulating nerves in the leg using wearable non-invasive neurostimulators, advantages are obtained when the target nerves are successfully stimulated by providing targeted stimulation while decreasing risk of, or avoiding, stimulation of non-target nerves and/or tissue such as calf muscle. Systems and methods which allow easy control of stimulation field characteristics (e.g., shape, strength, orientation, location, perceived intensity, and vector summation) should improve existing nerve modulation by improving treatment, user experience/comfort, and resulting therapy outcomes. Systems and methods are needed for allowing easy adjustability and confirmation of the correct settings of stimulation field characteristics. Operations related to selecting, adjusting, and assessing stimulation field characteristics are needed which can be carried out by a patient following instructions and providing feedback, by a medical professional in the setting of a medical clinic, at home by a user or caregiver, or a combination (e.g., remote telemedicine). Novel hardware and software controls and components; appropriately designed algorithms and logic flows; curated provision and adjustment of the therapy regimen features such as selection or assessme